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.

Reason: Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System.

Code information: 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.

Distribution pattern: 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***