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Verigene Processor SP with assay Luminex, VERIGENE… recallZ-2776-2020 · Luminex Corporation · initiated Jun 15, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

FDA root cause category: Device Design

What the company is doing

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 [email protected] 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 [email protected] www.luminexcorp.com

Recall details

Recall number
Z-2776-2020
Status
Terminated
Initiated by the company
Jun 15, 2020
Recalling firm
Luminex Corporation
Quantity
Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
Product code
PEN
FDA submissions
K132843
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.

Product description

Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

Code information (models, lots, serial numbers)

Show the full code information (28k characters)

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, 9336148, 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18344012, 18344013, 18344014, 18344015, 19023001, 19023002, 19023003, 19023004, 19023005, 19031001, 19031002, 19031003, 19031004, 19031005, 19031006, 19031007, 19031008, 19031009, 19031010, 19036001, 19036004, 19036005, 19036006, 19036007, 19036008, 19036009, 19036010, 19044001, 19044002, 19044003, 19044004, 19044005, 19044006, 19044007, 19044008, 19044009, 19044010, 19044011, 19044012, 19044013, 19044014, 19044015, 19057001, 19057003, 19057004, 19057005, 19057006, 19057007, 19057008, 19057009, 19057010, 19057011, 19057012, 19057014, 19057015, 19072002, 19072004, 19072005, 19072006, 19072007, 19072008, 19072009, 19072010, 19072011, 19072012, 19072013, 19072014, 19072015, 19084002, 19084003, 19084004, 19084005, 19084006, 19084007, 19084008, 19084009, 19084010, 19084014, 19092008, 19095001, 19095002, 19095003, 19095004, 19095005, 19095006, 19095007, 19095008, 19095009, 19095010, 19095011, 19095012, 19095013, 19095014, 19095015, 19123001, 19123003, 19123004, 19123006, 19123007, 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, 19325002, 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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, 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11276126, 11306134, 11306136, 11306138, 11306139, 11306140, 11306143, 11306146, 11306147, 11339150, 11339155, 12016005, 12016006, 12016007, 12016008, 12016009, 12016010, 12038019, 12038020, 12045024, 12045025, 12053031, 12053032, 12053033, 12053035, 12053040, 12061044, 12061046, 12061047, 12061049, 12069051, 12069053, 12069054, 12069058, 12079067, 12086074, 12086077, 12088090, 12107096, 12107100, 12111101, 12111102, 12111103, 12111104, 12111105, 12111106, 12111107, 12128113, 12128114, 12128115, 12128116, 12128117, 12128120, 12128121, 12136130, 12136131, 12136132, 12136133, 12136135, 12142139, 12142140, 12145145, 12145146, 12145148, 12156161, 12156162, 12170167, 12170178, 12175179, 12175180, 12175185, 12175186, 12175187, 12175188, 12175189, 12175190, 12175192, 12175193, 12198196, 12198197, 12198198, 12198199, 12198200, 12198201, 12198202, 12198203, 12198204, 12198205, 12198206, 12198207, 12198208, 12205209, 12205210, 12205211, 12205212, 12205213, 12205214, 12219229, 12219230, 12223241, 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13224281, 13224282, 13224285, 13224287, 13224288, 13227296, 13238301, 13238304, 13238305, 13238306, 13238307, 13238309, 13238310, 13245311, 13245312, 13245313, 13245314, 13245315, 13245318, 13274332, 13274334, 13274335, 13274336, 13274337, 13274340, 13301341, 13301344, 13301347, 13301350, 13315351, 13315353, 13315354, 13315355, 13315358, 13315359, 14006001, 14006009, 14043022, 14043023, 14043024, 14043026, 14043028, 14043029, 14043030, 14052033, 14052034, 14052036, 14062041, 14062042, 14062047, 14062050, 14069051, 14069052, 14069053, 14069060, 14083063, 14083064, 14083065, 14083066, 14083067, 14083068, 14083069, 14090079, 14111081, 14111084, 14111086, 14111087, 14118092, 14118093, 14139103, 14139104, 14139106, 14139107, 14139108, 14139109, 14139110, 14142111, 14142112, 14142114, 14142115, 14142116, 14155121, 14155122, 14155123, 14155124, 14155128, 14177133, 14177134, 14177137, 14177138, 14182142, 14182143, 14182149, 14182150, 14191153, 14191154, 14191155, 14191157, 14191158, 14211177, 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18037005, 18039004, 18039005, 18046002, 18046003, 18046004, 18046005, 18046010, 18057009, 18060009, 18060010, 18072004, 18072005, 18072009, 18088003, 18088004, 18088005, 18099006, 18120008, 18128004, 18141007, 18150003, 18150004, 18150006, 18156011, 18159014, 18159015, 18172008, 18177012, 18191012, 18205006, 18214007, 18226001, 18226007, 18226011, 18226012, 18226013, 18235005, 18235007, 18235009, 18250008, 18250013, 18255006, 18255008, 18255010, 18255015, 18264002, 18264006, 18264007, 18264008, 18288008, 18299007, 18299008, 18299012, 18318009, 18318015, 18333001, 18344004, 18344008, 19036002, 19036003, 19072006, 19072009, 19084011, 19084012, 19084013, 19084015, 19095001, 19095013, 19123005, 19295001, D09288101

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K132843 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85872).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page