Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1869-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 8, 2012

Date Posted: July 4, 2012

Recall Number: Z-1869-2012

Event ID: 61889

Reason for Recall:

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.

Status: Terminated

Product Quantity: 59,735

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***

Voluntary or Mandated:

Voluntary: Firm initiated