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.
Check against the official notice below — it lists the full affected range.
Luminex Corporation has recalled approximately 3,016 Verigene Processor SP systems (including both new and refurbished units) distributed worldwide and throughout the United States. The devices, which use disposable test consumables to perform blood culture testing, have an instrument failure mode that can produce false negative results for Gram-Positive or Gram-Negative blood cultures, potentially missing bacterial infections.
The recall affects specific serial numbers of the Verigene Processor SP (model 10-0000-07). The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
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. 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, J Quantity: Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished) Lot/code info: 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, 9336149, 9336150, 9336155, 9336156, 9336157, 9336158, 9350159, 9350160, 9350161, 9350163, 9350164, 9350165, 10014001, 10014003, 10014012, 10035017, 10035105, 10035106, 10043023, 10043024, 10043025, 10043027, 10099029, 10099032, 10099033, 10099037, 10102046, 10110047, 10110048, 10110050, 10110051, 10110052, 10110053, 10110055, 10110056, 10110057, 10110058, 10110060, 10110061, 10110062, 10119063, 10119064, 10119065, 10119066, 10139080, 10139081, 10139082, 10139083, 10139084, 10162085, 10162092, 10162093,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.