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.

Recall details

Manufacturer

Luminex Corporation

Distributor

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.

Lot

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, 10162094, 10182095, 10182096, 10182100, 10182101, 10182102, 10182103, 10182104, 10210105, 10210106, 10210107, 10210108, 10210109, 10210110, 10210111, 10210115, 10250117, 10250118, 10250119, 10250120, 10250121, 10250122, 10250123, 10276131, 10278128, 10278131, 10278132, 10278133, 10278163, 10295135, 10295136, 10295137, 10295138, 10295139, 10295140, 10295141, 10295142, 10295143, 10295144, 10295145, 10295146, 10295147, 10295149, 11021003, 11021008, 11101027, 11101028, 11122033, 11122034, 11152041, 11152042, 11152043, 11152044, 11152045, 11152046, 11152047, 11152048, 11152049, 11152050, 11152051, 11152052, 11152053, 11186054, 11186055, 11186056, 11186061, 11186062, 11186063, 11186064, 11186066, 11213071, 11213072, 11213073, 11213074, 11213075, 11213076, 11213078, 11213079, 11213080, 11213084, 11213085, 11236087, 11236089, 11236090, 11236091, 11236092, 11236093, 11250094, 11250095, 11250096, 11250098, 11250099, 11250100, 11250101, 11250103, 11250105, 11250106, 11250108, 11250109, 11276111, 11276112, 11276113, 11276114, 11276121, 11276122, 11276123, 11276124, 11276125, 11276127, 11276128, 11276129, 11306130, 11306131, 11306132, 11306133, 11306135, 11306136, 11306137, 11306141, 11306142, 11306144, 11306145, 11306146, 11306147, 11306148, 11306149, 11339151, 11339152, 11339153, 11339156, 11339157, 11339158, 11339159, 11339162, 11339163, 11339164, 12016001, 12016002, 12016003, 12016004, 12038011, 12038013, 12038014, 12038015, 12038016, 12038018, 12045021, 12045022, 12045023, 12045026, 12045027, 12045028, 12045029, 12045030, 12053034, 12053035, 12053036, 12053038, 12053039, 12053040, 12061041, 12061042, 12061043, 12061045, 12061048, 12061050, 12069052, 12069055, 12069056, 12069057, 12069058, 12069059, 12069060, 12079061, 12079062, 12079063, 12079064, 12079065, 12079066, 12079068, 12079069, 12079070, 12086071, 12086072, 12086073, 12086075, 12086076, 12086077, 12086078, 12086079, 12086080, 12088081, 12088082, 12088083, 12088084, 12088085, 12088086, 12088087, 12088088, 12088089, 12107091, 12107092, 12107093, 12107094, 12107095, 12107097, 12107098, 12111108, 12111109, 12111110, 12111111, 12111112, 12122056, 12128118, 12128119, 12128122, 12128123, 12128124, 12136125, 12136126, 12136127, 12136128, 12136134, 12136135, 12136136, 12142137, 12142138, 12142141, 12142142, 12145143, 12145144, 12145145, 12145146, 12145147, 12145148, 12145149, 12145150, 12145151, 12145152, 12145153, 12145154, 12156155, 12156156, 12156158, 12156160, 12156161, 12156162, 12156163, 12156164, 12156165,

Risk classification

Class II

Area (FDA)

device

Country

United States