Siemens Dimension Vista — Class II medical device recall Z-1869-2012

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2012-07-04, distributed nationwide. Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some p

Recall number	`Z-1869-2012`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Newark, DE, United States
Recall initiated	2012-05-08
Classified	2012-06-27
Reported by FDA	2012-07-04
Terminated	2014-04-03
Distributed	Nationwide (US)
Countries outside the US	AE, AT, BE, CA, CH, CZ, DE, DK, ES, FI, FR, IT, KR, NL, NO, NZ, PT, SK, ZA
Quantity	59,735
Lot numbers	`07304AA`, `08021AB`, `08042AC`, `08071AA`, `08114AC`, `09019AB`, `09019AC`, `09040AA`, `09068AA`, `09085AB`, `09110AE`, `09140AD`, `09180AC`, `09215AA`, `09236AC`, `09279AC`, `09307AA`, `10012AA`, `10039AA`, `10060AB`, `10074AB`, `10097AB`, `10109AD`, `10123AA`, `10138AB`, `10155AC`, `10181AA`, `10208AD`, `10208AE`, `10221AC`, `10237AD`, `10243AE`, `10265AB`, `10281AB`, `10301AC`, `10322AB`, `10341AC`, `10341AD`, `11012AB`, `11038AF` and 22 more
Expiration dates	`2008-05-28`, `2009-01-20`, `2009-02-10`, `2009-03-11`, `2009-04-23`, `2010-01-19`, `2010-02-10`, `2010-03-09`, `2010-03-26`, `2010-04-20`, `2010-05-19`, `2010-06-29`, `2010-08-03`, `2010-08-24`, `2010-10-06`, `2010-11-03`, `2011-01-13`, `2011-02-05`, `2011-03-01`, `2011-03-16`, `2011-04-07`, `2011-04-19`, `2011-05-03`, `2011-05-18`, `2011-06-03` and 34 more

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1869-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.