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U.S. Department of Health and Human Services

Class 2 Device Recall MagNA Pure LightCycler

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  Class 2 Device Recall MagNA Pure LightCycler see related information
Date Initiated by Firm July 21, 2011
Date Posted August 29, 2011
Recall Status1 Terminated 3 on July 02, 2012
Recall Number Z-3077-2011
Recall Event ID 59370
Product Classification Automated System; Nucleic Acids Isolation - Product Code LXG
Product MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.

An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
Code Information Series 1.0 software version 3.0.11, Part number 12236931001, Ser Numbers 28KN9Z70VE, LCPG0398, US03910905, US94800252, LCPD0020, LCPF0163, LCPG1291, LCPG1291, MXL5040CBZ, LCPE0042, CZC5252BDQ, LCPG1314, 2UA40207G6, LCPG0723, FRB3270KYX, LCPG0876, CZC5240354, US14111136, LCPG0426, USC326024W, LCPG0627, 29KN9ZP27C, LCPG0492, FRB3270H1D, LCPG0952, 2UA402049J, LCPG0711, LCPG0431, LCPG1070, LCPG0431, LCPG1070, USC3260241, USC3260241, CZC52403GR, CZC52403GR, CZC5252BDC, CZC5252BDC, LCPG0613, LCPG0613, LCPG1041, LCPG1041, CZC5251H2N, FRB3270JV7, FRB3270L5Y, LCPG0955, LCPG0956, 70018557, LCPG1252, FRB3270LQJ, LCPG0976, FRB3270KCK, LCPG0950, US14111105, CZC5231GH2, LCPG0320, LCPG1143, 2UA33504CM, LCPG0654, 2UB3370CMH, LCPG0689, 2UA4110GFH, MXL5310FQ7, CZC5251H5Z, LCPG0807, LCPG1161, LCPG1290, LCPG1290, US14110908, CZC5251G3F, LCPG0244, US10570146, CZC52402Y9, LCPF0131, US03910992, LCPF0178, USC325070Z, USU32703WY, LCPG0629, LCPG0663, USU32703WZ, LCPG0664, 28KN9ZK0Y9, CZC5252B9Z, LCPG0427, CZC521G1L, LCPG1071, FRB3270LQL, LCPG0983, LCPG1176, FRB3270LQT, LCPG1272, LCPG0973, 2AKN9Z0EM, LCPG0447, MXL4390NJC, LCPG0768, USC3250712, LCPG0626, 28KN9Z7039, US10570100, US13804158, US94800391, CZC5252BGI, LCPE0041, LCPF0128, LCPG0310, LCPG0432, FRB3270L25, LCPG0761, 51KN9ZE957, LCPG0524, US14110777, LCPG0418, US14110777, LCPG0418, LCPG1268, CZC5251GCB, US04552506, LCPF0165, LCPF0165, FRB3270G5Z, LCPG0942, 28KN9ZL0MV, USC3220T8R, LCPG1045, FRB3270LSD, LCPG0982, FRB3270LSD, LCPG0982, CZC52403GM, LCPG1033, 429000KH, LCPG0894, 70018555, 70018230, LCPG1226, CZC524038J, LCPG1042, LCPG1152, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, FRB32806ZY, LCPG0772, US14111131, LCPG0393, MXL4390NJB, LCPG0881, MXL4360D21, US14110727, SCZC52529XT, LCPG0306, FRB3270L1D, LCPG0842, 2UA43304Z2, LCPG0801, LCPG1292, LCPG1128, 2UB42002SG, CZC5252BHC, FRB32806D7, SVC1, LCPG0812, LCPG0930, LCPG0762, LCPG1306, 51KN9ZE943, LCPG0468, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0875, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0739, LCPG0740, LCPG0875, 2UB3370CRC, MXL4390NFJ, LCPG0769, LCPG0638, LCPG1036, CZC523187N, LCPG0294, MXL4360D1V, MXL4390NGT, USC326023Y, CZC5231FX5, CZC524035H, CZC5252B7K, CZC5252BOP, LCPG0572, LCPG0790, LCPG0791, LCPG1062, LCPG1162, LCPG1315, LCPG1318, FRB328070C, US14110905, CZC5240316, LCPG0396, LCPG1237, 2UB3370C62, LCPG0544, 29KN9ZP257, LCPG0537, US11303448, LCPG0252, FRB3270L0V, FRB3270L6P, LCPG0987, LCPG0932, FRB3270L1G, 2UA4020LMG, US04552507, LCPF0162, LCPF0162, LCPG0725, LCPG0725, 2UA431044W, CZC5257GHS, FRB32806CW, LCPG0411, LCPG0988, LCPG1037, 2UB3370CPR, US14111094, LCPG0399, LCPG0399, USU32703XT, 70018561, CZC5251GD5, CZC5252B76, LCPG0667, USC3220TSM, CZC5252BCV, LCPG0625, LCPG1069, 51KN9ZE964, LCPG0528, 2UB42002RV, LCPG0809, FRB3270LV3, LCPG0844, 2UB423087N, MXL4360CZS, USC325070H, 70018262, 70018263, 70018264, 70018558, 70018559, 70018560, LCPG0425, LCPG0634, LCPF0136, LCPF0136, LCPF0136, LCPG0265, LCPG0421, LCPG0421, LCPG0425, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0803, FRB328070L, LCPF0136, LCPG0265, LCPG0421, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0879, SCZC5252B5W, LCPG1321, LCPG1289, CZC5252BFR, LCPG00001289, 2UA4020483, LCPG0726, LCPG1032, CZC52403GH, LCPG1032, 429000KR, CZC5251G3L, CZC5251GSM, CZC5252B2Q, LCPG0893, LCPG1172, 28KN9ZX0T3, MXL4390NJ1, MXL4390NJ1, US04552482, US04552482, US13053013, US13053013, CZC5240314, CZC5252BCC, CZC525GZK, CZC525GZK, FRB3270L1V, FRB3270L1V, LCPF0173, LCPF0173, LCPG0293, LCPG0293, LCPG0376, LCPG0718, LCPG0718, LCPG0934, LCPG0934, LCPG1067, LCPG1067, LCPG1129, LCPG1129, LCPG1139, LCPG1139, LCPG1239, LCPG1239, LCPG1307, LCPG1307, LCPG1322, LCPG1324, LCPG1326, USW3190C0K, FRB3270L5V, LCPG0576, LCPG0971, 29KN9ZP1EE, LCPG0488, 51KN9ZE919, MXL4420B96, LCPG0895, FRB3270L0W, LCPG0864, CZC5252B9H, LCPG1282, 2UB3370B15, CZC52403GC, LCPG0730, LCPG1027, 2UA4020LFK, LCPG0641, FRB3270L09, LCPG0758, USC326023W, LCPG0631, 28KN9ZP0T0, LCPG0386, USU32703Y3, USU32703Y3, FRB3270LQR, FRB32806GB, LCPG0972, 2UB3370CQK, 2UB33803P7, CZC52529Z3, LCPG0669, FRB328072N, LCPG0891, MXL4420B9X, LCPG0901, 51KN9ZE929, LCPG0526, LCPG1288, 28KN9Z70VB, 2UB3370C1Z, 2UB3370CJZ, MXL4360D1N, MXL4390NGV, MXL4390NH1, MXL4390NJD, US14110846, LCPG0281, LCPG0373, LCPG0557, LCPG0566, LCPG0759, LCPG0767, FRB3270L4P, LCPG0985, FRB32806GD, FRB32806Y, LCPG1003, LCPG0783, CZC5252BGV, US04552498, LCPF0168, LCPF0168, FRB3270L12, LCPG0843, FRB3280732, LCPG0892, US04552474, US10570127, CZC52316, CZC5231GH5, LCPF0171, LCPF0130, CZC5251G1H, LCPG1253, LCPG0307, US94800162, LCPD0023, US03570619, LCPF0159, LCPG0786, US03910949, US13809040, LCPF0176, FRB3270KZL, LCPG0770, FRB328072F, LCPG0936, 2AKN9ZG01T, LCPG0440, US04552496, LCPF0169, MXL5040CBX, LCPG0680, MXL4390NHC, US14110747, LCPG0424, LCPG1113, LCPG0721, 2UA4020L7C, LCPG0540, US12754765, CZC5252BH3, 2UB3370C5S, LCPG0556, 2UB42002SF, LCPG0813, LCPG1312, 51KN9ZE925, 51KN9ZE971, LCPG0460, LCPG0467, 2UB33709QM, CZC5251GBX, LCPG0729, CZC5251H5V, SCZC52529X7, LCPG0302, CZC5231G6P, LCPG0616, LCPG1076, USC3260255, LCPG0616, LCPG1025, FRB328070R, LCPG0887, 2UA4020480, 2AKN9ZG011, 2AKN9ZG01E, LCPG0438, US14110776, US14111133, CZC52403G3, FRB3270L1Z, FRB328070H, LCPG0283, LCPG0300, 2UA4330426, MXL4360D0S, LCPG0793, 2UA4110GFC, 2UA4110GFB, LCPG0814, LCPG0299, US14110937, LCPG0420, US13804192, US14110820, LCPG1285, US14110820, USW3190C0R, LCPG0615, 2UA4020LMD, FRB3270LRT, LCPG0722, LCPG0975, US11303388, US11303620, US14014730, LCPG0251, LCPG0254, LCPG0423, 29KN9ZP1BP, LCPG0493, US14110994, SCZC5252B61, 28KN9Z70EX, LCPG0397, LCPG0383, US14110995, LCPG0232, USU32703VY, LCPG0571, US13804183, LCPG0295, 2UB3370C67, 2UB3370CR0, LCPG0677, LCPG0688, CZC52402Q4, LCPG1171, US14110928, LCPG0416, 2UA402048M, LCPG0715, US14014714, LCPG0241, US14014501, LCPG0243, 29KN9ZP1E8, LCPG0446, SCZC5252B4N, CZC5251GZH, FRB32806F8, LCPG0959, 29KN9ZP1TM, 2UA433044P, 2UB3370C5B, LCPG0495, LCPG0555, LCPG0787, US14111137, LCPG1310, LCPG0412, CZC5252BDW, LCPG0763, 2UA4220137, LCPG0763, 28KN9ZP0RJ, USU32703YD, LCPG0388, LCPG0665, LCPG1313, 2UA4020LB0, LCPG0705, USC2340J87, 29KN9ZP24L, CZC5252BHF, LCPG1107, CZC52402QY, LCPG0445, US03910979, LCPF0177, US14110854, LCPG0308, US11302407, LCPG0253, US13804157, CZC524030N, LCPG0301, 2UB33803QK, LCPG0437, FRB3270L1Q, LCPG0933, FRB3280727, LCPG1043, CZC524030P, CZC5240311, LCPG1174, LCPG1175, CZC52402QM, LCPG1244, LCPG1286, USW3190C09, LCPG0612, 2UB3370C6S, LCPG0558, MXL51603JZ, LCPG0962, FRB3270L08, LCPG0878, 2UB33706CW, LCPG0653, 2UB3370CR1, LCPG0687, 2UB3370C33, LCPG0543, 2UB3370CQ1, LCPG0685, MXL4360D1R, CZC2403GK, LCPG1026, LCPG0820, CZC524035C, FRB3280720, LCPG1110, SCZC52529Y6, SCZC5252B3T, LCPG0889, LCPG1319, LCPG1320, 29KN9ZP1ED, LCPG0533, US10570124, LCPF0129, 2UA431043K, LCPG0818, FRB3270L3X, LCPG0984, CZC52402PT, LCPG1164, FRB3270LL9, LCPG0951, MXL4390NHR, LCPG0771, MXL5040CC0, LCPG0968, FRB3270HKQ, LCPG0953, MXL4360D1L, LCPG0827, 2UA422011R, 2UA422088D, 2UA423087T, MXL4360D1Z, CZC5252BKP, CZC5252BL5, LCPD0019, LCPG0678, LCPG0802, LCPG0678, LCPG0802, LCPG0804, LCPG0678, LCPG0802, LCPG0804, CZC52403GP, LCPG1034, FRB32806DV, LCPG0989, US03570598, LCPF0158, CZC52403G2, LCPG1051, CZC5231FX1, CZC5252B9K, LCPG1061, 28KN9Z70SB, CZC5252BLC, LCPG1092, CZC524032R, LCPG1109, 2CKN9ZM19L, LCPG0534, CZC5252B7T, LCPG1166, USC3260246, LCPG0614, LCPG0553, CZC5252BBP, LCPG0405, FRB328072L, LCPG0681, 28KN9ZP1F5, LCPG0385, MXL5100795, CZC5251G63, LCPG1205, US14110830, FRB3270HJK, FRB3270LQ3, LCPG0417, 70018261, LCPG1228, 2UA433040P, LCPG0795, 28KN9ZL17N, LCPG0410, 2UA433032P, LCPG0764, CZC5231GHO, LCPG1073, CZC5252BJ3, LCPG0401, US13809118, LCPG0311, US04552493, LCPF0180, US94362911, LCPD0022, FRB32806F9, LCPG1000, USU32703XC, CZC52403GL, SU94362917, US03908709, LCPF0157, CZC524031G, US14110926, LCPG0415, LCPG1311, 51KN9ZE953, LCPG0456, CZC5251GW5, LCPG1046, 2UA4020LBG, LCPG0565, CZC5231FWZ, LCPG1056, 2AKN9ZG00B, LCPG0381, LCPG0381, 2UA4020LB3, CZC52402XX, LCPG1165, 2AKN9ZG00V, LCPG0434, SCZC5252B4G, 29KN9ZP1V5, LCPG0494, FRB32806FH, LCPG-0990, US03570644, LCPF0138, US14111089, US14111116, LCPG0309, CZC5251G2B, LCPG1072, FRB3270L84, LCPG0960, 2UA4110GFR, LCPG0784, LCPG1273, CZC524030F, PULLED, US14110814, LCPG0321, US14111141, LCPG0404, CZC525BQ5, 2AKN9ZF29B, LCPG0382, 2UA412034M, LCPG0785, LCPG0785, SCZC5252BD4, 2UA43104, LCPG0765, CZC5251GPH, LCPG1054, US14110879, LCPG00428, 28KN9ZL0DX, 28KN9ZL01J, LCPG0406, 2UB42002RY, CZC5251GDT, CZC5251GQH, FRB3270LQV, SCZC5252BOT, LCPG0810, LCPG0974, LCPG1090, LCPG1130, 28KN9ZL0HH, 28KN9ZL164, 2CKN9ZM11V, 2CKN9ZM19H, 2CKN9ZM1LV, 2CKN9ZV1M0, 2UA422010N, 2UB42002S4, US11303368, US11856174, US13813372, US94800510, CZC5240305, CZC5251GHN, LCPD0018, LCPG0255, LCPG0290, LCPG0387, LCPG0394, LCPG0403, LCPG0529, LCPG0530, LCPG0568, LCPG0569, LCPG0806, LCPG0811, LCPG0296, US13804095, US10570024, LCPF0126, 2UB42002SC, LCPG0815, LCPG0535, FRB3270KDV, LCPG0969, USW3190C0S, LCPG0623, US14111088, LCPG0298, FRB3270L6B, LCPG0986, CZC52402Y6, CZC5251GQF, LCPG0430, MXL5310FQK, CZC5252B4N, 28KN9ZN0H7, LCPG0584, 2CKN9ZV1M7, 2CKN9ZV1M7, LCPG0575, LCPG0575, LCPG0808, LCPG0828, 28KN9ZL027, LCPG0408, 2UA4330438, LCPG0766, CZC5252BHQ, LCPG1098, CZC5252BF7, LCPG1275, LCPG0491, 2UA42200Z1, LCPG0496, 28KN9ZL0PZ, 2UA41106JL, US94800373, CZC5231FWQ, CZC5251H0Z, CZC5252BJP, FRB3270LRH, FRB32806FY, 90314720(LCPG0310), LCP-E0042, LCPG-0297, LCPG0250, LCPG0384, LCPG0392, LCPG0405, LCPG0414, LCPG0422, LCPG0531, LCPG0564, LCPG1163 and LCPG1213.
Recalling Firm/
Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information Contact Roche Technical Services
800-526-1247 Ext. 249
Manufacturer Reason
for Recall
Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.
FDA Determined
Cause 2
Action Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled "URGENT MEDICAL DEVICE CORRECTION" to all affected customers. The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue. For questions on this recall please call Roche at (800) 428-5074.
Quantity in Commerce 422
Distribution Nationwide Distribution; including the islands of Puerto Rico and Hawaii.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.