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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene Processor SP

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  Class 2 Device Recall Verigene Processor SP see related information
Date Initiated by Firm June 15, 2020
Create Date August 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2775-2020
Recall Event ID 85872
510(K)Number K122514  
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
Product Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Code Information Verigene Processor SP, 10-0000-07, GTIN 00840487101483, Serial Numbers: 902, 907, 908, 909, 911, 912, 9098001, 9098002, 9098003, 9098005, 9098006, 9100009, 9100011, 9100012, 9100014, 9121015, 9121017, 9121018, 9121019, 9121021, 9121022, 9135024, 9135026, 9135027, 9135028, 9135029, 9163034, 9163035, 9163038, 9163039, 9163040, 9163041, 9163042, 9163043, 9163044, 9163045, 9163046, 9202047, 9202050, 9202051, 9202052, 9202053, 9202054, 9210055, 9210056, 9210057, 9210058, 9210059, 9210061, 9210062, 9230063, 9230064, 9230065, 9230066, 9230067, 9230068, 9230069, 9230070, 9230074, 9230075, 9255071, 9255072, 9255077, 9255079, 9255080, 9270080, 9270082, 9270084, 9270085, 9270086, 9270087, 9277088, 9277089, 9277090, 9277091, 9277092, 9277093, 9277094, 9288095, 9288096, 9288097, 9288102, 9293103, 9293106, 9293109, 9293111, 9298112, 9298116, 9298117, 9298118, 9313119, 9313120, 9313121, 9313122, 9313123, 9313124, 9320127, 9325138, 9325151, 9325152, 9336144, 9336145, 9336146, 9336147, 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19123008, 19123009, 19123010, 19140001, 19140002, 19140003, 19140004, 19140005, 19140006, 19140007, 19140008, 19140009, 19140010, 19155001, 19155002, 19155003, 19155004, 19155005, 19155006, 19155007, 19155008, 19155009, 19155010, 19192001, 19192002, 19192003, 19192004, 19192005, 19192006, 19192007, 19192008, 19192009, 19192010, 19206001, 19206002, 19206003, 19206004, 19206006, 19206007, 19206008, 19206009, 19206010, 19233001, 19233002, 19233003, 19233004, 19233005, 19233007, 19233008, 19233009, 19233010, 19260001, 19260002, 19260004, 19260005, 19260006, 19260007, 19260008, 19260009, 19260010, 19281001, 19281002, 19281003, 19281004, 19281005, 19282001, 19282002, 19282003, 19282004, 19282005, 19295001, 19295002, 19295003, 19295004, 19295005, 19295006, 19295007, 19295008, 19295009, 19295010, 19305001, 19305002, 19305003, 19305004, 19305005, 19305006, 19305007, 19305008, 19305009, 19305010, 19317001, 19317002, 19317003, 19317004, 19317005, 19317007, 19317008, 19317009, 19317010, 19325001, 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D0908, D0909, D0912, D09135024, D09255073, D09313126, D09320128, D09320129, D09320130, D09320131, D09320132, D09320133, D09320134, D09320135, D09325135, D09325136, D09336157, D09336158, D908    Verigene Processor SP, Refurbished, 10-0000-07R, GTIN 00840487101490, Serial Numbers: 9100008, 9100013, 9121016, 9135023, 9135030, 9163032, 9163033, 9163036, 9202049, 9255076, 9270079, 9270081, 9270083, 9277087, 9288098, 9288099, 9288100, 9293104, 9293105, 9293107, 9293108, 9293110, 9298111, 9313125, 9325137, 9325139, 9325140, 9325141, 9325142, 9336143, 9336151, 9336152, 9336153, 9336154, 9350166, 10014002, 10014004, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10035013, 10035014, 10035015, 10035016, 10035017, 10035018, 10035019, 10035020, 10043021, 10043022, 10043026, 10099030, 10099031, 10099035, 10099036, 10099038, 10099039, 10099040, 10099041, 10099042, 10099043, 10099044, 10102045, 10110059, 10119072, 10119075, 10119077, 10119078, 10139079, 10162086, 10162088, 10162090, 10162091, 10182097, 10182098, 10182099, 10210112, 10210113, 10210114, 10250115, 10250124, 10278125, 10278126, 10278127, 10278129, 10278130, 10278134, 10295150, 10295151, 10295152, 10295153, 10295154, 10336155, 10336156, 10336157, 10336158, 10336159, 10336160, 10336161, 10336162, 10336163, 10336164, 10350165, 10350166, 10350167, 10350168, 10350169, 10350170, 10350171, 10350172, 11021001, 11021002, 11021004, 11021005, 11021006, 11021007, 11021008, 11040009, 11040010, 11040011, 11040012, 11040014, 11040015, 11040016, 11068017, 11068018, 11068019, 11068020, 11068021, 11068022, 11068023, 11068024, 11101025, 11101026, 11101028, 11101029, 11101030, 11101031, 11101032, 11122035, 11122036, 11122037, 11122038, 11122039, 11122040, 11186057, 11186058, 11186059, 11186064, 11186065, 11186066, 11213067, 11213068, 11213069, 11213070, 11213082, 11213083, 11213085, 11213086, 11236087, 11236088, 11250090, 11250091, 11250092, 11250097, 11250104, 11276110, 11276115, 11276116, 11276117, 11276118, 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12219230, 12223241, 12223244, 12223245, 12223246, 12223247, 12223248, 12229249, 12229250, 12229253, 12229254, 12229255, 12229256, 12229257, 12233260, 12233261, 12233265, 12240287, 12240288, 12248289, 12248293, 12248294, 12248295, 12248297, 12248298, 12254299, 12254300, 12254301, 12254302, 12254303, 12261313, 12261315, 12268323, 12268324, 12268325, 12268326, 12268327, 12268328, 12271329, 12271330, 12271331, 12271332, 12271333, 12271334, 12271335, 12271336, 12271337, 12271338, 12278339, 12278341, 12278342, 12278343, 12278344, 12278345, 12278347, 12278348, 12285356, 12285357, 12285358, 12292359, 12292363, 12292368, 12303369, 12303370, 12303371, 12303372, 12303373, 12303374, 12305381, 12305383, 12305384, 12310389, 12310390, 12310391, 12310392, 12310393, 12310396, 12310398, 12317400, 12317401, 12317402, 12317403, 12317404, 12317406, 12317407, 12317408, 12324411, 12324412, 12333426, 12333427, 12333428, 12340438, 13003003, 13003008, 13008011, 13008013, 13008014, 13008017, 13018024, 13018027, 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14191158, 14211177, 14211180, 14218181, 14218182, 14224199, 14230202, 14230203, 14230204, 14230205, 14237215, 14244221, 14244230, 14251233, 14251234, 14251237, 14251238, 14251239, 14251240, 14265241, 14265245, 14265246, 14307256, 14307257, 14307258, 14307259, 14307260, 14322261, 14322262, 14322267, 14322269, 15015004, 15020012, 15020013, 15020014, 15020015, 15020016, 15020017, 15033021, 15033022, 15033024, 15033025, 15040033, 15055044, 15055046, 15075051, 15075053, 15075056, 15075060, 15131071, 15131072, 15131079, 15208081, 15208087, 15208088, 15208089, 15327109, 16049001, 16049002, 16077013, 16125025, 16242041, 16242043, 16277053, 16299061, 16299062, 16299066, 17062026, 17096031, 17096032, 17096033, 17096035, 17096037, 17117044, 17130059, 17177002, 17215005, 17215008, 17215009, 17262010, 17284001, 17284006, 17284009, 17296005, 17296006, 17296007, 17296008, 17296009, 17296010, 17307001, 17307003, 17333001, 17340004, 17347001, 18022003, 18023007, 18024002, 18026003, 18037001, 18037002, 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Recalling Firm/
Manufacturer
Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
512-219-8020
Manufacturer Reason
for Recall
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
FDA Determined
Cause 2
Device Design
Action On 06/10/2020, the firm sent a letter to customers titled, "MEDICAL DEVICE FIELD ACTION", regarding an instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. The firm has developed a software solution that identifies and alerts users to the issue. The firm will contact customers to verify their address to ship the software material and provide installation information. Once the update has been completed, customers need to email a screen shot of the updated software, as well as a completed Notice of Destruction to Global Support Services at support@luminexcorp.com to complete the upgrade process. The firm is also stating that until the updated software is installed, it is important, and part of good laboratory practice, that the customer follow the specific guidelines indicated in the current package inserts. Specifically, "Not Detected" test results from a positive blood culture should be evaluated further. The sub-culturing of blood cultures is necessary, per the intended use section within the Package Inserts in the Kits. For any questions contact the firm's Global Support Service at: 1.877.785.2323 (US) 1.512.381.4397 (OUS/CANADA) 512.219.5114 support@luminexcorp.com www.luminexcorp.com
Quantity in Commerce Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.
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 = PAM and Original Applicant = NANOSPHERE, INC
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