Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1675-2018·Announced 2018-05-16

Siemens IMMULITE Assays Recalled for Biotin Interference Risk

Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin interference is not documented in the instructions, potentially affecting test accuracy.

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 hazard is a documentation issue regarding biotin interference limits rather than a direct contamination or structural defect. No injuries or illnesses are reported, and the risk is related to potential test inaccuracy rather than immediate physical harm, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the IMMULITE 2000/IMMULITE 2000 XPi Anti HBc assay. The recall is due to the fact that the concentration of biotin that does not interfere with the test is not currently listed in the instructions for use. This lack of documentation means the assay is susceptible to interference from biotin, which could impact the accuracy of the results.

The affected product is the Anti HBc assay, with specific lot codes including 579, 580, 581, D579, D580, D581, and D602. The source text notes that this issue also affects other Siemens assays, including those for 3gAllergy Specific IgE, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, as well as Dimension and ADVIA Centaur assays.

The distribution of the affected product was nationwide in the United States, as well as in Canada, Mexico, and Thailand. Healthcare providers and laboratories using these assays should verify their lot numbers against the recall list and follow the instructions provided by Siemens Healthcare Diagnostics regarding the handling of these specific tests.

The recalled product

Product: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
mis-labeling

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 (1)

Anti HBc

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 →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · biotin interference