The Recall Desk
ModerateFDA (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.

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 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
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 →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

Same hazard · biotin interference

See all →