Siemens IMMULITE Assay Recalled Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.
What this means for you
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 describes a labeling omission regarding biotin interference thresholds rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE /IMMULITE 1000 BR-MA (CA15-3) assay. The recall is due to the fact that the instruction for use does not currently list the concentrations of biotin that do not interfere with the test. Consequently, the assay is susceptible to interference from biotin, which may affect the accuracy of the results.
The affected products include lot codes 0312 and 0313. These products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The recall also notes that other specific assays, including 3gAllergy Specific IgE, anti-HBc, CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, are similarly susceptible to biotin interference and lack listed non-interference concentrations in their instructions for use.
Healthcare providers and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had these tests performed should consult their healthcare provider to discuss the potential impact of biotin interference on their results.
The recalled product
- Product
- IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
- 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 (5)
- BR-MA/CA15-3
- BR-MA/CA15-3 (IMMULITE/IMMULITE 1000
- LKBR1)
- (IMMULITE 2000/IMMULITE 2000 XPi
- LKBR2) Lot codes: 0312 0313
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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