Reported Jul 4, 2012 · Terminated
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 GBC Drive, Mailstop 514 · Newark, DE · 19714-6101
Is this the product you have?
- 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.
- Lot codes and dates
- 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.
- Amount recalled
- 59,735
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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