Z-0476-2021 Class II Terminated

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.

UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 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18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 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