Device Recall Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge

  • Model / Serial
    B12 Flex(R) reagent cartridge (K6442) - IFBA Interference All lots -- 07304AA, Exp 5/28/08; 08021AB, Exp 1/20/09; 08042AC, Exp 2/10/09; 08071AA, Exp 3/11/09; 08114AC, Exp 4/23/09; 09019AC, Exp 1/19/10; 09019AB, Exp 1/19/10; 09040AA, Exp 2/10/10; 09068AA, Exp 3/9/10; 09085AB, Exp 3/26/10; 09110AE, Exp 4/20/10; 09140AD, Exp 5/19/10; 09180AC, Exp 6/29/10; 09215AA, Exp 8/3/10; 09236AC, Exp 8/24/10; 09279AC, Exp 10/6/10; 09307AA, Exp 11/3/10; 10012AA, Exp 1/13/11; 10039AA, Exp 2/5/11; 10060AB, Exp 3/1/11; 10074AB, Exp 3/16/11; 10097AB, Exp 4/7/11; 10109AD, Exp 4/19/11; 10123AA, Exp 5/3/11; 10138AB, Exp 5/18/11; 10155AC, Exp 6/3/11; 10181AA, Exp 7/1/11;  10208AE, Exp 7/27/11; 10208AD, Exp 7/27/11; 10221AC, Exp 8/9/11; 10237AD, Exp 8/25/11; 10243AE, Exp 8/31/11; 10265AB, Exp 9/22/11; 10281AB, Exp 10/8/11; 10301AC, Exp 10/28/11; 10322AB, Exp 11/18/11; 10341AC, Exp 12/6/11; 10341AD, Exp 12/7/11; 11012AB, Exp 1/13/12; 11038AF, Exp 2/9/12;  11038AG, Exp 2/8/12; 11066AE, Exp 3/7/12; 11087AD, Exp 3/27/12; 11118AB, Exp 4/28/12; 11145AA, Exp 5/24/12; 11171AA, Exp 6/21/12; 11234AA, Exp 8/21/12; 11234AB, Exp 8/21/12; 11250AA, Exp 9/6/12; 11263AA, Exp 9/19/12; 11283AA, Exp 10/9/12; 11297AB, Exp 10/23/12; 11312AA, Exp 11/6/12; 11332AA, Exp 11/27/12; 11346AA, Exp 12/11/12; 11361AB, Exp 12/27/12; 12011AA, Exp 1/15/13; 12030AB, Exp 1/30/13; 12044AB, Exp 2/13/12; 12059AB, Exp 3/27/13; 12079AB, Exp 3/18/13; and 12093AB, Exp 4/1/13.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britian, Italy, Netherlands, Norway, Portugal, Slovakia, South Africa, Spain, Switzerland, United Arab Emirates, Canada, New Zealand, and South Korea. *** Center Recommended Depth is Retail***
  • Product Description
    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) || B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
  • Source
    USFDA