FDAFDA · Alimentos y medicamentos·N.º oficial Z-2776-2020
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.
Publicado el 19 de agosto de 2020 · Inicio del retiro: 15 de junio de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Luminex Corporation
- Distribuidor
- 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.
- Lote
- 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,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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