Siemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing
Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.
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, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling errors or low-risk contamination issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,050 kits of the ADVIA Centaur Syphilis (SYPH) Assay, Reference Number 10492493. The recall is due to interference with the HBsAg (Hepatitis B surface antigen) assay, which may impact the accuracy of diagnostic results.
The affected product is an in vitro diagnostic immunoassay used for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma. The recall covers kits distributed worldwide, including the United States, Brazil, China, Denmark, Hong Kong, Malaysia, New Zealand, and Viet Nam. Specific lot numbers and expiration dates are listed in the official recall documentation.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasm
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 2,050
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 (16)
- US Lot Number/Exp. Date 85456003 2012-10-13
- 86036003 2012-10-13
- 87129003 2012-10-13
- 88440003 2012-10-13
- 90054004 2013-04-09
- 90422004 2013-04-09. Outside the US: Kit lots
- 77749002
- 80615003
- 82640003
- 84120003
- 85456003
- 86036003
- 87129003
- 88440003
- 90054004
- 90422004.
Distribution
Distributed nationwide across the United States.
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