Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the instructions fail to disclose known interference risks (biotin), creating a risk of harm due to potential misdiagnosis. No illnesses or injuries have been reported in the source text, and the agency classification is Class II, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of IMMULITE assays, including OM-MA (CA125), 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, Thyroglobulin, and Vitamin B12. The recall affects products distributed nationwide in the United States as well as in Canada, Mexico, and Thailand.
The reason for the recall is that the instruction for use for these assays does not currently list the concentrations of biotin that do not interfere with test results. Consequently, these specific assays are susceptible to interference from biotin, which could lead to inaccurate diagnostic outcomes for patients.
The recalled product
- Product
- IMMULITE 2000/IMMULITE ¿ 2000 XPi 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) 287 289 290
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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