Siemens B12 Reagent Cartridges Recalled for False Test Results
Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where the hazard is a false test result that could lead to misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista System B12 Flex Reagent Cartridge (K6442). The recall covers 59,735 units distributed worldwide, including the United States, Canada, and various countries in Europe, Asia, and Africa.
The recall is due to a potential for false and significant elevations in reported Vitamin B12 concentrations. This issue occurs when Intrinsic Factor Blocking Antibodies are present in some patients. The defect affects all lots of the B12 Flex reagent cartridges used with the Dimension Vista System.
Healthcare facilities and laboratories should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for instructions on return or replacement. Patients who have had Vitamin B12 tests using this system may need to consult their healthcare providers regarding the validity of their results.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 59,735
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 09040AA
- Exp 2/10/10
- 09068AA
- Exp 3/9/10
- 09085AB
- Exp 3/26/10
- 09110AE
Distribution
Distributed nationwide across the United States.
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