Siemens IMMULITE CA125 Assay Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE CA125 assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
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. The hazard involves potential test inaccuracy due to biotin interference, which is a significant quality issue but does not involve reported injuries or deaths, fitting the Moderate criteria for low-risk contamination or labeling/instruction issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE /IMMULITE 1000 OM-MA (CA125) 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 include lot codes 0211, 0212, and 0213. The distribution pattern is listed as nationwide and in Canada, Mexico, and Thailand. The recall notice also mentions that other Siemens assays, including those for 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, Thyroglobulin, and Vitamin B12, are susceptible to biotin interference and lack listed non-interference concentrations.
Consumers and healthcare providers should check their inventory for the specific lot codes listed. If the product is found, it should be returned to Siemens Healthcare Diagnostics, Inc. according to the recall instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
- 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)
- OM-MA (CA125)
- OM-MA (CA125) (IMMULITE/IMMULITE 1000
- LKOP1)
- (IMMULITE 2000/IMMULITE 2000 XPi
- LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213
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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