Z-0477-2021 Class II Terminated

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, 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 VERIGENE SP 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, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 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, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015