Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1690-2018·Announced 2018-05-16

Siemens ADVIA Centaur HBc IgM Recalled for Biotin Interference

Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.

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 involves potential test interference from biotin, which is a low-risk contamination or labeling issue where the specific interference threshold is not documented, fitting the criteria for a moderate severity recall without reported injuries.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur HBc IgM test. 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 instruction for use. As a result, the assay is susceptible to interference from biotin.

The recall affects 6 units of the product. The products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The specific lot codes affected are listed in the agency's recall record, including lots added in 2020 and 2021.

Consumers and healthcare providers should stop using the affected test kits and contact Siemens Healthcare Diagnostics for further instructions or a replacement.

The recalled product

Product: ADVIA Centaur¿ HBc IgM
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
mis-labeling
Affected units: 6

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 (6)

ADVIA Centaur¿ HBc IgM
test
hepatitis b (b core
be antigen
be antibody
b core igm)

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 →

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Same hazard · biotin interference