Siemens IMMULITE 2000 BR-MA (CA15-3) Assay Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.
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 documentation issue regarding biotin interference thresholds rather than a direct physical defect or reported injury, aligning with the 'Moderate' criteria for labeling/documentation issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) assay. The recall affects specific lots of the product, including lot numbers 265, 266, and 267. The product was distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
The recall is issued because the instructions for use do not currently list the concentrations of biotin that do not interfere with the assay. The source text indicates that the BR-MA (CA15-3) assay is susceptible to interference from biotin. This lack of specific information in the documentation may affect the accuracy of test results.
Healthcare facilities and users of the IMMULITE 2000/IMMULITE 2000 XPi systems should check their inventory for the affected lot numbers. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement products.
The recalled product
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 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) CA15-3(BR-MA) Lot # 265 266 267
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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