Verigene Processor SP with assay Luminex recalled

Yes. Luminex recalled Verigene Processor SP with assay Luminex, Verigene Gram-Negative Blood Culture Nucleic on 15 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2776-2020.

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

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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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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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, 18037003, 18037004, 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

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.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.