Siemens IMMULITE Vitamin B12 Assay Recalled Due to Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a labeling omission regarding biotin interference, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE and IMMULITE 1000 Vitamin B12 assays. The recall is due to the fact that the concentrations of biotin that do not interfere with the test are not currently listed in the instructions for use. The source text notes that these assays are susceptible to interference from biotin.
The affected products are distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The specific lot codes involved in this recall are 0338, 0339, 0340, and 0341. The recall number is Z-1686-2018.
Healthcare providers and laboratories should stop using the affected lots of the Vitamin B12 assay. Users should contact Siemens Healthcare Diagnostics for further instructions on how to handle the recalled product and to ensure that patient results are not compromised by potential biotin interference.
The recalled product
- Product
- IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (3)
- Vitamin B12
- Vitamin B12 (IMMULITE/IMMULITE 1000
- LKVB1) Lot codes: 0338 0339 0340 0341
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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