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.
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 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.
See all 24 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · biotin interference
See all →- HighBeckman Coulter Access Free T4 Thyroxine Assay Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
- HighBeckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
- ModerateBeckman Coulter Access Total T3 Assay Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
- ModerateBeckman Coulter Free T3 Immunoassay Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
- ModerateBeckman Coulter Access GI Monitor Cancer Antigen 19-9 Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
Similar recalls
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- HighSiemens IMMULITE PSA Kit Recall Due to Negative Bias Results
FDA (Devices) · 2017-02-08
- ModerateSiemens Creatine Kinase MB Assay Recalled for Drug Interference
FDA (Devices) · 2018-05-16
- HighSiemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference
FDA (Devices) · 2017-03-15
- ModerateSiemens IMMULITE Total IgE Assay Recalled for Positive Bias
FDA (Devices) · 2014-05-07
- LowSiemens IMMULITE Calcitonin Control Module Recalled for Typographical Error
FDA (Devices) · 2014-11-19