Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-1869-2012

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

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.

Status

Terminated

Initiated

2012-05-08

Posted

2012-06-27

Terminated

2014-04-03

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.

Root cause

Device Design

Action

Siemens Healthcare Diagnostics Inc. sent a Urgent Device Recall letter to all affected customers dated May 2012. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to immediately discontinue use of the device, quarantine and dispose of all inventory, ensure that your Medical Director reviews this letter as well as the attached physician letter. Please complete the attached Field Correction form and fax to 302-631-8467. Further questions please call 302-631-6311.

Quantity

59,735

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***

Lot, serial or model codes

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.

510(k) numbers

["K071224"]

PMA numbers

not on file

Product code

CDD

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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