Siemens IMMULITE 2000 Folic Acid Assay Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.
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. The hazard is a labeling omission regarding biotin interference, which is a moderate risk of diagnostic error rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi Folic Acid assay. 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 Folic Acid assays with lot numbers 502, 503, 504, 505, 506, 508, and 514. The products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
Healthcare providers and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
- 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 (3)
- Folic Acid
- Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2
- L2KFO6) Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514
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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