Class 2 Device Recall BIOFIRE FILMARRAY TORCH (BIOFIRE TORCH)

• Date Initiated by Firm: August 07, 2024
• Date Posted: September 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3123-2024
• Recall Event ID: 95019
• 510(K)Number: K160068
• Product Classification: Respiratory virus panel nucleic acid assay system - Product Code OCC
• Product: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
• Code Information: HTFA-ASY-0003, UDI: 00815381020277, Serial Numbers: KTM01040, KTM03252, KTM05330, KTM05411, KTM05602, KTM05734, KTM05800, KTM05810, KTM05887, KTM05997, KTM06000, KTM06003, KTM06005, KTM06038, KTM06057, KTM06063, KTM06139, KTM06639, KTM06756, KTM06870, KTM06902, KTM07116, KTM13705, KTM13710, KTM13815, KTM14196, KTM14329, KTM14357, KTM14918, KTM15242, KTM15798, KTM15801, KTM15819, KTM17194, KTM17531, KTM17570, KTM17576, KTM17696, KTM17812, KTM18083, KTM18448, KTM18453, KTM18464, KTM18559, KTM19173, KTM19183, KTM19386, KTM20255, KTM20260, KTM20273, KTM20280, KTM20296, KTM20299, KTM20301, KTM20308, KTM20314, KTM20318, KTM20321, KTM20324, KTM20325, KTM20330, KTM20354, KTM20398, KTM20403, KTM20502, KTM13752, KTM18382, KTM19197, KTM19634, KTM19610, KTM20269, KTM21459, KTM00143, KTM00173, KTM00221, KTM00230, KTM00237, KTM01401, KTM01437, KTM01439, KTM01446, KTM00247, KTM07097, KTM07224, KTM07422, KTM09682, KTM10535, KTM10550, KTM12833, KTM13438, KTM14845, KTM18045, KTM15398, KTM01947, KTM04128, KTM05500, KTM05501, KTM06798, KTM06929, KTM08608, KTM08780, KTM08830, KTM08977, KTM10092, KTM10527, KTM11388, KTM11583, KTM11617, KTM11624, KTM11687, KTM12214, KTM12456, KTM12622, KTM12637, KTM13777, KTM13784, KTM14421, KTM14536, KTM15336, KTM15984, KTM16048, KTM16148, KTM16426, KTM16708, KTM16729, KTM17030, KTM17237, KTM17427, KTM20259, KTM20262, KTM20272, KTM20281, KTM20287, KTM20291, KTM20295, KTM20306, KTM20311, KTM20313, KTM20317, KTM20326, KTM20339, KTM20340, KTM20357, KTM17378, KTM20242, KTM03150, KTM20239, KTM20240, KTM20245, KTM20305, KTM02088, KTM20352, KTM18296, KTM04024, KTM04291, KTM04336, KTM04339, KTM15727, KTM01193, KTM03483, KTM03828, KTM03835, KTM03837, KTM04108, KTM05011, KTM05574, KTM05641, KTM05686, KTM06842, KTM06847, KTM06882, KTM07019, KTM07039, KTM07088, KTM07093, KTM07094, KTM07292, KTM07331, KTM07734, KTM07976, KTM07994, KTM08495, KTM08496, KTM10488, KTM13627, KTM13862, KTM16633, KTM16676, KTM16721, KTM17960, KTM17970, KTM18062, KTM19036, KTM19142, KTM19304, KTM20140, KTM20303. HTFA-ASY-0003-W, UDI: 00815381029089, Serial Numbers: KTM00005, KTM00013, KTM00033, KTM00039, KTM00040, KTM00041, KTM00044, KTM00046, KTM00050, KTM00053, KTM00054, KTM00056, KTM00059, KTM00060, KTM00064, KTM00074, KTM00076, KTM00077, KTM00080, KTM00081, KTM00088, KTM00090, KTM00105, KTM00112, KTM00119, KTM00136, KTM00138, KTM00140, KTM00152, KTM00156, KTM00175, KTM00178, KTM00183, KTM00190, KTM00194, KTM00202, KTM00203, KTM00219, KTM00227, KTM00232, KTM00234, KTM00236, KTM00238, KTM00241, KTM00249, KTM00250,KTM00251,KTM00253, KTM00262, KTM00263,KTM00265, KTM00275, KTM00291, KTM00293, KTM00295, KTM00298, KTM00299,KTM00303, KTM00307, KTM00308, KTM00312, KTM00318,KTM00322, KTM00325, KTM00341, KTM00345, KTM00350, KTM00352, KTM00354, KTM00361, KTM00364, KTM00382, KTM00383, KTM00384, KTM00385, KTM00395, KTM00401,KTM00403, KTM00408, KTM00417, KTM00419, KTM00422, KTM00432, KTM00438, KTM00441, KTM00448, KTM00458,KTM00462, KTM00480, KTM00483, KTM00487, KTM00491, KTM00493, KTM00510, KTM00514, KTM00523, KTM00529, KTM00533, KTM00535, KTM00555, KTM00556, KTM00560, KTM00578, KTM00580, KTM00581, KTM00583, KTM00596, KTM00597, KTM00600, KTM00611, KTM00617, KTM00618, KTM00621, KTM00627, KTM00642, KTM00658, KTM00661, KTM00680, KTM00683, KTM00684, KTM00697, KTM00707, KTM00711, KTM00717, KTM00723, KTM00733, KTM00734, KTM00735, KTM00747, KTM00753, KTM00755, KTM00756, KTM00761, KTM00762, KTM00766, KTM00771, KTM00785, KTM00788, KTM00789, KTM00804, KTM00817, KTM00818, KTM00819, KTM00821, KTM00826, KTM00834, KTM00838, KTM00840, KTM00843, KTM00845, KTM00853, KTM00854, KTM00855, KTM00856, KTM00858, KTM00859, KTM00861, KTM00864, KTM00876, KTM00879, KTM00881, KTM00884, KTM00901, KTM00911, KTM00919, KTM00935, KTM00944, KTM00946, KTM00947, KTM00948, KTM00968, KTM00974, KTM00980, KTM00987, KTM00989, KTM00994, KTM00996, KTM00999, KTM009C5, KTM01004, KTM01007, KTM01009, KTM01017, KTM01019, KTM01024, KTM01035, KTM01038, KTM01042, KTM01043, KTM01045, KTM01048, KTM01052, KTM01054.KTM01058, KTM01061, KTM01064, KTM01071, KTM01077, KTM01083, KTM01085, KTM01090, KTM01105, KTM01110, KTM01113, KTM01129, KTM01135, KTM01153, KTM01158, KTM01164, KTM01166, KTM01171, KTM01175, KTM01181, KTM01191, KTM01197, KTM01203, KTM01228, KTM01234, KTM01242, KTM01263, KTM01265, KTM01273, KTM01276, KTM01278, KTM01284, KTM01292, KTM01297, KTM01302, KTM01315, KTM01316, KTM01325, KTM01327, KTM01349, KTM01355, KTM01361, KTM01367, KTM01372, KTM01373, KTM01379, KTM01380, KTM01386, KTM01390, KTM01394, KTM01395, KTM01399, KTM01421, KTM01443, KTM01445, KTM01447, KTM01449, KTM01452, KTM01470, KTM01480, KTM01494, KTM01508, KTM01516, KTM01518, KTM01519, KTM01533, KTM01535, KTM01536, KTM01541, KTM01545, KTM01561, KTM01566, KTM01569, KTM01571, KTM01581, KTM01590, KTM01599, KTM01612, KTM01613, KTM01618, KTM01620, KTM01625, KTM01629, KTM01631, KTM01649, KTM01650, KTM01652, KTM01674, KTM01683, KTM01698, KTM01699, KTM01705, KTM01711, KTM01716, KTM01718, KTM01723, KTM01726, KTM01730, KTM01736, KTM01738, KTM01742, KTM01743, KTM01744, KTM01745, KTM01760, KTM01767, KTM01774, KTM01775, KTM01776, KTM01778, KTM01783, KTM01787, KTM01789, KTM01790, KTM01792, KTM01795, KTM01799, KTM01802, KTM01803, KTM01811, KTM01818, KTM01834, KTM01836, KTM01838, KTM01846, KTM01858, KTM01863, KTM01867, KTM01877, KTM01878, KTM01882, KTM01883, KTM01902, KTM01903, KTM01912, KTM01925, KTM01944, KTM01954, KTM01962, KTM01969, KTM01973, KTM01982, KTM01989, KTM01990, KTM01994, KTM01995, KTM02012, KTM02013, KTM02014, KTM02015, KTM02028, KTM02047, KTM02059, KTM02061, KTM02063, KTM02064, KTM02068, KTM02075, KTM02082, KTM02083, KTM02092, KTM02094, KTM02099, KTM02110, KTM02123, KTM02125, KTM02128, KTM02133, KTM02134, KTM02135, KTM02139, KTM02142, KTM02143, KTM02150, KTM02152, KTM02156, KTM02159, KTM02162, KTM02163, KTM02174, KTM02184, KTM02186, KTM02188, KTM02209, KTM02210, KTM02212, KTM02214, KTM02216, KTM02220, KTM02222, KTM02224, KTM02225, KTM02235, KTM02239, KTM02242, KTM02246, KTM02247, KTM02249, KTM02270, KTM02271, KTM02280, KTM02286, KTM02297, KTM02298, KTM02300, KTM02321, KTM02324, KTM02329, KTM02334, KTM02336, KTM02342, KTM02343, KTM02344, KTM02351, KTM02353, KTM02357, KTM02361, KTM02365, KTM02366, KTM02367, KTM02369, KTM02372, KTM02373, KTM02374, KTM02375, KTM02376, KTM02383, KTM02387, KTM02390, KTM02391, KTM02393, KTM02394, KTM02402, KTM02404, KTM02405, KTM02406, KTM02407, KTM02413, KTM02417, KTM02418, KTM02423, KTM02427, KTM02437, KTM02449, KTM02452, KTM02462, KTM02477, KTM02481, KTM02482, KTM02484, KTM02487, KTM02497, KTM02502, KTM02518, KTM02531, KTM02540, KTM02546, KTM02548, KTM02552, KTM02554, KTM02562, KTM02573, KTM02578, KTM02581, KTM02582, KTM02585, KTM02599, KTM02602, KTM02604, KTM02627, KTM02629, KTM02632, KTM02633, KTM02645, KTM02647, KTM02650, KTM02655, KTM02657, KTM02658, KTM02666, KTM02670, KTM02673, KTM02677, KTM02681, KTM02685, KTM02695, KTM02702, KTM02704, KTM02713, KTM02717, KTM02720, KTM02722, KTM02733, KTM02735, KTM02736, KTM02741, KTM02747, KTM02750, KTM02753, KTM02757, KTM02782, KTM02798, KTM02800, KTM02807, KTM02824, KTM02825, KTM02848, KTM02849, KTM02851, KTM02860, KTM02868, KTM02879, KTM02882, KTM02890, KTM02907, KTM02915, KTM02923, KTM02928, KTM02932, KTM02934, KTM02935, KTM02942, KTM02948, KTM02960, KTM02964, KTM02979, KTM02981, KTM02984, KTM02988, KTM02999, KTM03004, KTM03005, KTM03008, KTM03021, KTM03022, KTM03037, KTM03043, KTM03057, KTM03062, KTM03086, KTM03093, KTM03102, KTM03105, KTM03106, KTM03117, KTM03130, KTM03138, KTM03139, KTM03160, KTM03172, KTM03190, KTM03211, KTM03213, KTM03216, KTM03219, KTM03221, KTM03225, KTM03226, KTM03232, KTM03233, KTM03258, KTM03267, KTM03270, KTM03271, KTM03274,KTM03276, KTM03278, KTM03281, KTM03282, KTM03285, KTM03286, KTM03289, KTM03292, KTM03309, KTM03316, KTM03322, KTM03325, KTM03326, KTM03327, KTM03338, KTM03341, KTM03347, KTM03349, KTM03351, KTM03357, KTM03358, KTM03361, KTM03362, KTM03389, KTM03397, KTM03402, KTM03406, KTM03410, KTM03413, KTM03415, KTM03418, KTM03424, KTM03425, KTM03429, KTM03430, KTM03434, KTM03435, KTM03436, KTM03447, KTM03453, KTM03457, KTM03459, KTM03461, KTM03470, KTM03471, KTM03476, KTM03480, KTM03481, KTM03484, KTM03491, KTM03504, KTM03505, KTM03510, KTM03520, KTM03521, KTM03522, KTM03527, KTM03547, KTM03550, KTM03553, KTM03562, KTM03565, KTM03571, KTM03577, KTM03580, KTM03582, KTM03589, KTM03591, KTM03603, KTM03615, KTM03619, KTM03626, KTM03627, KTM03638, KTM03639, KTM03640, KTM03646, KTM03660, KTM03661, KTM03662, KTM03664, KTM03669, KTM03673, KTM03677, KTM03680, KTM03683, KTM03686, KTM03694, KTM03701, KTM03703, KTM03708, KTM03711, KTM03715, KTM03722, KTM03723, KTM03724, KTM03729, KTM03731, KTM03734, KTM03736, KTM03738, KTM03748, KTM03753, KTM03755, KTM03760, KTM03761, KTM03771, KTM03775, KTM03776, KTM03784, KTM03788, KTM03790, KTM03803, KTM03811, KTM03814, KTM03817, KTM03818, KTM03823, KTM03832, KTM03839, KTM03843, KTM03849, KTM03850, KTM03858, KTM03860, KTM03868, KTM03873, KTM03876, KTM03885, KTM03887, KTM03889, KTM03892, KTM03898, KTM03910, KTM03912, KTM03914, KTM03916, KTM03937, KTM03943, KTM03946, KTM03953, KTM03958, KTM03963, KTM03976, KTM03990, KTM03994, KTM03997, KTM03998, KTM03999, KTM04005, KTM04006, KTM04008, KTM04011, KTM04014, KTM04017, KTM04018, KTM04028, KTM04032, KTM04037, KTM04041, KTM04050, KTM04056, KTM04059, KTM04064, KTM04066, KTM04067, KTM04077, KTM04079, KTM04081, KTM04082, KTM04091, KTM04094, KTM04099, KTM04102, KTM04110, KTM04115, KTM04118, KTM04121, KTM04127, KTM04130, KTM04131, KTM04137, KTM04141, KTM04154, KTM04164, KTM04166, KTM04169, KTM04177, KTM04180, KTM04185, KTM04201, KTM04205, KTM04207, KTM04210, KTM04215, KTM04226, KTM04227, KTM04234, KTM04242, KTM04243, KTM04254, KTM04256, KTM04265, KTM04268, KTM04272, KTM04275, KTM04277, KTM04282, KTM04286, KTM04295, KTM04300, KTM04303, KTM04304, KTM04321, KTM04322, KTM04331, KTM04333, KTM04335, KTM04338, KTM04341, KTM04345, KTM04360, KTM04365, KTM04369, KTM04370, KTM04376, KTM04378, KTM04395, KTM04401, KTM04403, KTM04404, KTM04405, KTM04409, KTM04419, KTM04422, KTM04435, KTM04451, KTM04455, KTM04458, KTM04464, KTM04469, KTM04472, KTM04484, KTM04485, KTM04486, KTM04503, KTM04506, KTM04510, KTM04517, KTM04528, KTM04537, KTM04546, KTM04547, KTM04551, KTM04555, KTM04562, KTM04566, KTM04571, KTM04577, KTM04582, KTM04586, KTM04590, KTM04593, KTM04612, KTM04616, KTM04620, KTM04627, KTM04632, KTM04638, KTM04641, KTM04642, KTM04667, KTM04670, KTM04672, KTM04721, KTM04722, KTM04739, KTM04742, KTM04754, KTM04765, KTM04783, KTM04785, KTM04801, KTM04803, KTM04810, KTM04813, KTM04816, KTM04827, KTM04834, KTM04835, KTM04846, KTM04847, KTM04849, KTM04850, KTM04862, KTM04865, KTM04881, KTM04882, KTM04888, KTM04933, KTM04934, KTM04942, KTM04950, KTM04953, KTM04958, KTM04964, KTM04966, KTM04977, KTM0497A, KTM04981, KTM04982, KTM04988, KTM04989, KTM04991, KTM04994, KTM05002, KTM05004, KTM05005, KTM05007, KTM05008, KTM05019, KTM05021, KTM05034, KTM05038, KTM05039, KTM05040, KTM05048, KTM05052, KTM05058, KTM05062, KTM05070, KTM05077, KTM05081, KTM05088, KTM05090, KTM05097, KTM05098, KTM05107, KTM05112, KTM05113, KTM05119, KTM05124, KTM05126, KTM05131, KTM05132, KTM05138, KTM05140, KTM05143, KTM05144, KTM05155, KTM05186, KTM05194, KTM05195, KTM05214, KTM05219, KTM05222, KTM05225, KTM05228, KTM05229, KTM05235, KTM05240, KTM05244, KTM05255, KTM05260, KTM05265, KTM05267, KTM05270, KTM05281, KTM05289, KTM05290, KTM05303, KTM05304, KTM05307, KTM05311, KTM05316, KTM05319, KTM05326, KTM05327, KTM05328, KTM05338, KTM05352, KTM05357, KTM05369, KTM05371, KTM05373, KTM05375, KTM05385, KTM05389, KTM05395, KTM05396, KTM05421, KTM05424, KTM05435, KTM05442, KTM05451, KTM05453, KTM05454, KTM05467, KTM05468, KTM05470, KTM05493, KTM05494, KTM05504, KTM05507, KTM05517, KTM05519, KTM05521, KTM05522, KTM05526, KTM05529, KTM05535, KTM05536, KTM05541, KTM05549, KTM05552, KTM05554, KTM05555, KTM05561, KTM05567, KTM05571, KTM05576, KTM05579, KTM05582, KTM05584, KTM05597, KTM05604, KTM05623, KTM05628, KTM05630, KTM05635, KTM05638, KTM05676, KTM05677, KTM05683, KTM05687, KTM05696, KTM05698, KTM05710, KTM05714, KTM05717, KTM05728, KTM05737, KTM05741, KTM05742, KTM05745, KTM05751, KTM05764, KTM05769, KTM05772, KTM05777, KTM05797, KTM05805, KTM05811, KTM05813, KTM05814, KTM05815, KTM05817, KTM05826, KTM05832, KTM05836, KTM05839, KTM05840, KTM05844, KTM05851, KTM05852, KTM05858, KTM05865, KTM05868, KTM05873, KTM05879, KTM05881, KTM05882, KTM05883, KTM05892, KTM05894, KTM05898, KTM05902, KTM05906, KTM05907, KTM05908, KTM05918, KTM05921, KTM05923, KTM05924, KTM05926, KTM05932, KTM05933, KTM05934, KTM05940, KTM05949, KTM05954, KTM05957, KTM05963, KTM05968, KTM05971, KTM05974, KTM05977, KTM05978, KTM05980, KTM05985, KTM05990, KTM05991, KTM05993, KTM05995, KTM06008, KTM06009, KTM06018, KTM06022, KTM06026, KTM06032, KTM06039, KTM06040, KTM06043, KTM06047, KTM06051, KTM06061, KTM06073, KTM06076, KTM06080, KTM06096, KTM06102, KTM06104, KTM06106, KTM06120, KTM06149, KTM06152, KTM06156, KTM06161, KTM06163, KTM06164, KTM06169, KTM06185, KTM06190, KTM06191, KTM06199, KTM06204, KTM06206, KTM06207, KTM06208, KTM06211, KTM06219, KTM06220, KTM06225, KTM06228, KTM06233, KTM06236, KTM06240, KTM06245, KTM06248, KTM06252, KTM06255, KTM06257, KTM06258, KTM06261, KTM06264, KTM06273, KTM06280, KTM06284, KTM06285, KTM06292, KTM06295, KTM06296, KTM06302, KTM06311, KTM06325, KTM06328, KTM06335, KTM06339, KTM06343, KTM06346, KTM06347, KTM06354, KTM06362, KTM06365, KTM06369, KTM06376, KTM06377, KTM06384, KTM06385, KTM06386, KTM06389, KTM06393, KTM06394, KTM06398, KTM06406, KTM06408, KTM06418, KTM06427, KTM06429, KTM06434, KTM06435, KTM06447, KTM06454, KTM06455, KTM06460, KTM06475, KTM06481, KTM06485, KTM06488, KTM06489, KTM06512, KTM06520, KTM06523, KTM06527, KTM06532, KTM06533, KTM06534, KTM06549, KTM06550, KTM06554, KTM06559, KTM06560, KTM06561, KTM06563, KTM06564, KTM06578, KTM06585, KTM06591, KTM06604, KTM06617, KTM06627, KTM06628, KTM06634, KTM06643, KTM06644, KTM06654, KTM06669, KTM06670, KTM06675, KTM06681, KTM06682, KTM06685, KTM06688, KTM06691, KTM06692, KTM06696, KTM06699, KTM06701, KTM06713, KTM06720, KTM06723, KTM06733, KTM06735, KTM06769, KTM06770, KTM06780, KTM06787, KTM06789, KTM06796, KTM06797, KTM06803, KTM06810, KTM06814, KTM06815, KTM06825, KTM06831, KTM06840, KTM06848, KTM06849, KTM06852, KTM06859, KTM06860, KTM06861, KTM06866, KTM06874, KTM06877, KTM06884, KTM06886, KTM06891, KTM06893, KTM06909, KTM06921, KTM06923, KTM06938, KTM06953, KTM06954, KTM06959, KTM06960, KTM06973, KTM06974, KTM06980, KTM06987, KTM06992, KTM06996, KTM06997, KTM06BE4, KTM07001, KTM07006, KTM07010, KTM07013, KTM07021, KTM07023, KTM07026, KTM07029, KTM07047, KTM07056, KTM07057, KTM07059, KTM07061, KTM07062, KTM07063, KTM07066, KTM07071, KTM07076, KTM07109, KTM07113, KTM07122, KTM07130, KTM07133, KTM07139, KTM07147, KTM07153, KTM07163, KTM07167, KTM07171, KTM07173, KTM07174, KTM07195, KTM07200, KTM07203, KTM07211, KTM07212, KTM07217, KTM07227, KTM07235, KTM07243, KTM07247, KTM07248, KTM07252, KTM07262, KTM07275, KTM07290, KTM07296, KTM07305, KTM07312, KTM07335, KTM07339, KTM07341, KTM07346, KTM07359, KTM07366, KTM07376, KTM07402, KTM07411, KTM07412, KTM07415, KTM07421, KTM07423, KTM07425, KTM07427, KTM07429, KTM07430, KTM07432, KTM07435, KTM07448, KTM07456, KTM07463, KTM07470, KTM07471, KTM07473, KTM07477, KTM07483, KTM07485, KTM07486 ,KTM07497, KTM07498, KTM07505, KTM07509, KTM07523, KTM07526, KTM07529, KTM07542, KTM07545, KTM07546, KTM07547, KTM07572, KTM07588, KTM07594, KTM07613, KTM07635, KTM07639, KTM07646, KTM07647, KTM07650, KTM07651, KTM07654, KTM07658, KTM07664, KTM07669, KTM07670, KTM07716, KTM07717, KTM07718, KTM07724, KTM07739, KTM07755,KTM07762, TM07771, TM07772, KTM07792, KTM07796, KTM07802, KTM07815, KTM07840, TM07847, KTM07864, KTM07870, KTM07875, KTM07879, KTM07890, KTM07902, KTM07926, KTM07929, KTM07945, KTM07991, KTM08015, KTM08064, TM08098, KTM08130, KTM08139, KTM08140, KTM08144, KTM08146, KTM08147, KTM08155, KTM08165, KTM08173, KTM08180, KTM08188, TM08190, KTM08200, KTM08209, TM08218, KTM08236, KTM08239, KTM08242, KTM08252, KTM08269, KTM08272, KTM08288, KTM08291, KTM08303,KTM08305, KTM08308, KTM08316, KTM08337, KTM08346, KTM08362, KTM08373, KTM08411, KTM08415, KTM08438, KTM08462, KTM08478, KTM08479, KTM08503, KTM08506, KTM08510,KTM08527, KTM08556,KTM08565,KTM08566, KTM08572, KTM08581, KTM08583, KTM08588, KTM08600, KTM08602, KTM08603, KTM08614, KTM08623, KTM08628, KTM08635, KTM08642, KTM08657, KTM08661, KTM08664, KTM08666, KTM08669, KTM08677, KTM08678, TM08681, KTM08684, KTM08686, KTM08692, KTM08693, KTM08695, KTM08702, KTM08703, KTM08710, KTM08712, KTM08715, KTM08720, KTM08722, KTM08743, KTM08750, KTM08754, KTM08756, KTM08768, KTM08769, KTM08775, KTM08792, KTM08810, KTM08814, KTM08815, KTM08832, KTM08834, KTM08837, KTM08840, KTM08849, KTM08852, KTM08855, KTM08857, KTM08871, KTM08881, KTM08896, KTM08913, KTM08917, KTM08922, KTM08924, KTM08925, KTM08933, KTM08940, KTM08941, KTM08943, KTM08956, KTM08964, KTM08978, KTM08979, KTM08980, KTM08991, KTM08996, KTM08998, KTM09003, KTM09004, KTM09009, KTM09010, KTM09014, KTM09019, KTM09021, KTM09027, KTM09028, KTM09030, KTM09033, KTM09053, KTM09056, KTM09058, KTM09068, KTM09070, KTM09078, KTM09104, KTM09105, KTM09110, KTM09112, KTM09116, KTM09117, KTM09120, KTM09137, KTM09138, KTM09139, KTM09147, KTM09154, KTM09162, KTM09164, KTM09166, KTM09177, KTM09178, KTM09181, KTM09193, KTM09208, KTM09212, KTM09217, KTM09220, KTM09223, KTM09251, KTM09264, KTM09269, KTM09274, KTM09280, KTM09292, KTM09294, KTM09311, KTM09316, KTM09323, KTM09334, KTM09350, KTM09361, KTM09370, KTM09371, KTM09382, KTM09386, KTM09391, KTM09405, KTM09407, KTM09416, KTM09422, KTM09425, KTM09431, KTM09441, KTM09449, KTM09450, KTM09452, KTM09470, KTM09480, KTM09492, KTM09501, KTM09503, KTM09506, KTM09509, KTM09511, KTM09520, KTM09527, KTM09530, KTM09536, KTM09542, KTM09547, KTM09556, KTM09571, KTM09578, KTM09591, KTM09603, KTM09604, KTM09610, KTM09611, KTM09633, KTM09642, KTM09648, KTM09649, KTM09657, KTM09662, KTM09671, KTM09674, KTM09687, KTM09690, KTM09704, KTM09705, KTM09717, KTM09719, KTM09724, KTM09725, KTM09737, KTM09742, KTM09752, KTM09762, KTM09763, KTM09777, KTM09779, KTM09782, KTM09784, KTM09785, KTM09793, KTM09802, KTM09803, KTM09811, KTM09813, KTM09814, KTM09821, KTM09823, KTM09826, KTM09832, KTM09834, KTM09835, KTM09839, KTM09844, KTM09846, KTM09848, KTM09854, KTM09865, KTM09872, KTM09882, KTM09892, KTM09897, KTM09901, KTM09911, KTM09913, KTM09933, KTM09942, KTM09948, KTM09951, KTM09958, KTM09965, KTM09982, KTM09988, KTM09989, KTM0BB79, KTM0CF31, KTM0F1D0, KTM10009, KTM10021, KTM10041, KTM10097, KTM10102, KTM10128, KTM10131, KTM10134, KTM10137, KTM10139, KTM10144, KTM10152, KTM10158, KTM10161, KTM10168, KTM10173, KTM10176, KTM10178, KTM10186, KTM10191, KTM10192, KTM10193, KTM10198, KTM101C3, KTM10203, KTM10230, KTM10234, KTM10246, KTM10255, KTM10265, KTM10268, KTM10275, KTM10285, KTM10293, KTM10294, KTM10297, KTM10298, KTM10301, KTM10305, KTM10309, KTM10311, KTM10315, KTM10335, KTM10340, KTM10343, KTM10351, KTM10362, KTM10375, KTM10379, KTM10386, KTM10389, KTM10390, KTM10395, KTM10420, KTM10422, KTM10434, KTM10438, KTM10439, KTM10444, KTM10450, KTM10456, KTM10471, KTM10478, KTM10485, KTM10501, KTM10526, KTM10556, KTM10579, KTM10586, KTM10588, KTM10603, KTM10611, KTM10652, KTM10665, KTM10674, KTM10729, KTM10731, KTM10737, KTM10745, KTM10752, KTM10754, KTM10761, KTM10765, KTM10770, KTM10777, KTM10782, KTM10784, KTM10803, KTM10822, KTM10828, KTM10835, KTM10872, KTM10877, KTM10885, KTM10890, KTM10900, KTM10902, KTM10906, KTM10928, KTM10945, KTM10946, KTM10956, KTM10983, KTM10985, KTM10987, KTM10997, KTM10998, KTM10AEB, KTM11027, KTM11047, KTM11048, KTM11060, KTM11062, KTM11083, KTM11098, KTM11112, KTM11120, KTM11129, KTM11138, KTM11141, KTM11147, KTM11166, KTM11172, KTM11182, KTM11184, KTM11193, KTM11194, KTM11204, KTM11207, KTM11209, KTM11213, KTM11221, KTM11222, KTM11224, KTM11230, KTM11237, KTM11249, KTM11256, KTM11257, KTM11258, KTM11264, KTM11268, KTM11280, KTM11286, KTM11291, KTM11299, KTM112BC, KTM11305,KTM11307, KTM11311, KTM11330, KTM11351, KTM11358, KTM11359, KTM11361, KTM11363, KTM11372, KTM11397, KTM11398, KTM11401, KTM11415, KTM11418, KTM11431, KTM11433, KTM11466, KTM11477, KTM11482, KTM11491, KTM11511, KTM11516, KTM11549, KTM11561, KTM11564, KTM11597, KTM11627, KTM11631, KTM11661, KTM11674, KTM11676, KTM11707, KTM11715, KTM11742, KTM11820, KTM11827, KTM11871, KTM11875, KTM11879, KTM11883, KTM11884, KTM11891, KTM11893, KTM11913, KTM11919, KTM11922 ,KTM11965, KTM11966, KTM12014, KTM12017, KTM12018, KTM12033, KTM12057, KTM12070, KTM12120, KTM12121, KTM12158, KTM12161, KTM12191, KTM12197, KTM12213, KTM12215, KTM12224, KTM12225, KTM12229, KTM12240, KTM12243, KTM12245, KTM12256, KTM12258, KTM12262, KTM12269, KTM12271, KTM12279, KTM12280, KTM12298, KTM12302, KTM12303, KTM12305, KTM12307, KTM12308, KTM12352, KTM12355, KTM12356, KTM12361, KTM12363, KTM12364, KTM12365, KTM12367, KTM12396, KTM12405, KTM12437, KTM12444, KTM12455, KTM12473, KTM12474, KTM12478, KTM12484, KTM12486, KTM12488, KTM12489, KTM12497, KTM12498, KTM12506, KTM12512, KTM12524, KTM12534, KTM12547, KTM12557, KTM12561, KTM12574, KTM12576, KTM12585, KTM12587, KTM12597, KTM12607, KTM12640, KTM12645, KTM12648, KTM12650, KTM12654, KTM12660, KTM12666, KTM12670, KTM12678, KTM12679, KTM12684, KTM12692, KTM12697, KTM12698, KTM12701, KTM12707, KTM12709, KTM12710, KTM12711, KTM12715, KTM12716, KTM12718, KTM12719, KTM12722, KTM12724, KTM12733, KTM12741, KTM12755, KTM12757, KTM12761, KTM12777, KTM12778, KTM12781, KTM12782, KTM12803, KTM12822, KTM12844, KTM12847, KTM12865, KTM12878, KTM12884, KTM12891, KTM12893, KTM12903, KTM12939, KTM12946, KTM12950, KTM12952, KTM12961, KTM12976, KTM12999, KTM13007, KTM13023, KTM13024, KTM13035, KTM13042, KTM13051, KTM13054, KTM13059, KTM13060, KTM13062, KTM13063, KTM13067, KTM13076, KTM13079, KTM13089, KTM13101, KTM13104, KTM13115, KTM13116, KTM13157, KTM13159, KTM13170, KTM13174, KTM13224, KTM13238, KTM13242, KTM13253, KTM13258, KTM13270, KTM13271, KTM13287, KTM13304, KTM13309, KTM13312, KTM13314, KTM13316, KTM13321, KTM13326, KTM13336, KTM13343, KTM13348, KTM13353, KTM13357, KTM13361, KTM13365, KTM13367, KTM13372, KTM13378, KTM13382, KTM13385, KTM13390, KTM13394, KTM13395, KTM13407, KTM13413, KTM13420, KTM13427, KTM13433, KTM13434, KTM13437, KTM13440, KTM13441, KTM13442, KTM1345B, KTM13462, KTM13467, KTM13481, KTM13487, KTM13492, KTM13494, KTM13496, KTM13500, KTM13513, KTM13515, KTM13525, KTM13526, KTM13528, KTM13541, KTM13543, KTM13559, KTM13598, KTM13613, KTM13621, KTM13636, KTM13637, KTM13641, KTM13645, KTM13649, KTM13663, KTM13665, KTM13671, KTM13689, KTM13692, KTM13694, KTM13712, KTM13716, KTM13717, KTM13724, KTM13731, KTM13732, KTM13755, KTM13760, KTM13761, KTM13766, KTM13769, KTM13786, KTM13789, KTM13795, KTM13796, KTM13804, KTM13839, KTM13848, KTM13857, KTM13864, KTM13874, KTM13915, KTM13920, KTM13936, KTM13939, KTM13945, KTM13946, KTM13953, KTM13958, KTM13959, KTM14016, KTM14022, KTM14036, KTM14085, KTM14086, KTM14105, KTM14108, KTM14118, KTM14120, KTM14124, KTM14128, KTM14130, KTM14134, KTM14137, KTM14153, KTM14161, KTM14163, KTM14164, KTM14167, KTM14192, KTM14218, KTM14224, KTM14226, KTM14230, KTM14232, KTM14241, KTM14245, KTM14263, KTM14267, KTM14269, KTM14291, KTM14292, KTM14313, KTM14315, KTM14318, KTM14321, KTM14328, KTM14330, KTM14331, KTM14345, KTM14347, KTM14359, KTM14375, KTM14387, KTM14394, KTM14398, KTM14413, KTM14427, KTM14447, KTM14453, KTM14460, KTM14485, KTM14488, KTM14490, KTM14515, KTM14520, KTM14521, KTM14522, KTM14524, KTM14529, KTM14541, KTM14544, KTM14549, KTM14551, KTM14563, KTM14572, KTM14597, KTM14622, KTM14623, KTM14640, KTM14641, KTM14642, KTM14651, KTM14654, KTM14662, KTM14664, KTM14665, KTM14672, KTM14683, KTM14695, KTM14696, KTM14706, KTM14709, KTM14710, KTM14742, KTM14770, KTM14790, KTM14793, KTM14794, KTM14799, KTM14801, KTM14805, KTM14811, KTM14812, KTM14818, KTM14823, KTM14831, KTM14832, KTM14835, KTM14839, KTM14846, KTM14849, KTM14850, KTM14852, KTM14861, KTM14873, KTM14888, KTM14892, KTM14905, KTM14915, KTM14922, KTM14923, KTM14934, KTM14941, KTM14963, KTM14985, KTM14C56, KTM15001, KTM15015, KTM15020, KTM15021, KTM15026, KTM15033, KTM15042, KTM15043, KTM15050, KTM15066, KTM15068, KTM15079, KTM15089, KTM15092, KTM15094, KTM15101, KTM15105, KTM15127, KTM15130, KTM15131, KTM15133, KTM15140, KTM15148, KTM15150, KTM15151, KTM15153, KTM15159, KTM15160, KTM15185, KTM15189, KTM15196, KTM15225, KTM15232, KTM15236, KTM15257, KTM15270, KTM15274, KTM15280, KTM15303, KTM15306, KTM15310, KTM15311, KTM15313, KTM15329, KTM15357, KTM15365, KTM15373, KTM15382, KTM15384, KTM15390, KTM15403, KTM15415, KTM15422, KTM15429, KTM15431, KTM15450, KTM15463, KTM15466, KTM15470, KTM15474, KTM15481, KTM15486, KTM15488, KTM15501, KTM15522, KTM15535, KTM15539, KTM15544, KTM15568, KTM15583, KTM15587, KTM15592, KTM15595, KTM15623, KTM15643, KTM15673, KTM15674, KTM15692, KTM15694, KTM15702, KTM15704, KTM15721, KTM15722, KTM15730, KTM15734, KTM15742, KTM15764, KTM15777, KTM15796, KTM15797, KTM15814, KTM15834, KTM15856, KTM15883, KTM15885, KTM15892, KTM158B0, KTM15902, KTM15904, KTM15916, KTM15929, KTM15942, KTM15952, KTM15958, KTM15963, KTM15965, KTM15985, KTM15990, KTM15995, KTM16005, KTM16011, KTM16052, KTM16062, KTM16066, KTM16068, KTM16072, KTM16075, KTM16090, KTM16106, KTM16133, KTM16138, KTM16179, KTM16191, KTM16194, KTM16231, KTM16242, KTM16247, KTM16272, KTM16274, KTM16305, KTM16312, KTM16327, KTM16333, KTM16349, KTM16383, KTM16395, KTM16398, KTM16413, KTM16418, KTM16420, KTM16429, KTM16437, KTM16439, KTM16442, KTM16493, KTM16501, KTM16559, KTM16597, KTM16598, KTM16630, KTM16653, KTM16732, KTM16735, KTM16736, KTM16741, KTM16749, KTM16750, KTM16814, KTM16829, KTM16843, KTM16844, KTM16847, KTM16868, KTM16869, KTM16873, KTM16875, KTM16879, KTM16892, KTM16900, KTM16904, KTM16906, KTM16907, KTM16910, KTM16912, KTM16916, KTM16917, KTM16926, KTM16937, KTM16949, KTM16950, KTM16969, KTM16975, KTM16984, KTM16987, KTM16999, KTM17001, KTM17007, KTM17012, KTM17021, KTM17025, KTM17027, KTM17042, KTM17043, KTM17046, 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KTM20492, KTM65F00, KTMF44C1, TM01521, TM02004, KTM12460, KTM15711, KTM17008, KTM20377, KTM20391, KTM03815, KTM07179, KTM07586, KTM08186, KTM05315, KTM06607, KTM15756, KTM00693, KTM03119, KTM03125, KTM03127, KTM12543, KTM03894, KTM08233, KTM05042, KTM03560, KTM02833, KTM07124, KTM11094, KTM16181, KTM18572, KTM20367, KTM04281, KTM01453, KTM01474, KTM01682, KTM02275, KTM02549, KTM02951, KTM03081, KTM04814, KTM08056, KTM12843, KTM15941, KTMB48F2 HTFA-ASY-0003U, UDI: 00815381020277, Serial Number: TM03611
• FEI Number: 3002773840
• Recalling Firm/ Manufacturer: BioFire Diagnostics, LLC; 515 S Colorow Dr; Salt Lake City UT 84108-1248
• For Additional Information Contact: Customer Support Department; 800-736-6354
• Manufacturer Reason for Recall: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
• FDA Determined Cause: Under Investigation by firm
• Action: On 8/7/24 Biomerieux sent recall notices to customers who were asked to do the following: 1) Utilize http://biofiredx.com/fsca5788-1/ to determine which of your instruments are impacted. 2) If your instrument is on the impacted list, it needs to be returned to the firm's Service Center for recalibration; your local contact will reach out to you to coordinate instrument return. 3) Continue to use all your instruments in accordance with product labeling (instructions for use) while waiting for service. 4) For BIOFIRE GI Panel Users, you may continue using the product as directed in the package insert, but if a positive Salmonella or Giardia lamblia result is inconsistent with clinical presentation, consider confirming the positive using another method or rerun the sample on an unaffected instrument. In patients suspected of Norovirus infection, please consider confirming Norovirus results via another method prior to reporting those results or rerun the sample on an unaffected instrument. 5) For BCID2 users, you may continue using the product as directed in the package insert; however, in patients with a Staphylococcus aureus detected result on the BCID2 panel AND suspected of a MRSA infection, please confirm all negative MRSA results via another method prior to reporting or rerun the sample on an unaffected instrument. 6) For RP2.1, RP2.1plus, ME, PN, PNplus and JI users, you may continue using the product as directed in the package insert; No confirmation of results are required. 7) If you have further distributed impacted instrument(s), identify any recipients and notify them at once by sending them a copy of the recall notice and acknowledgement form. 8) Complete all fields of the accompanying Acknowledgment of Receipt Form via email and return to USfieldactions@biomerieux.com or the form can be filled out electronically by following URL: https://www.biofiredx.com/recall5788-1/ Customers with questions can contact Technical Support at biofiresupport@biomer
• Quantity in Commerce: 3,439
• Distribution: Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OCC