Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.
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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a potential for inaccurate diagnostic results due to quality control failures, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur BR Assay, an in vitro diagnostic test used to measure cancer antigen CA 27.29 in human serum. The recall involves 15,455 kits distributed nationwide in the United States and in several international markets, including Australia, Brazil, Canada, Colombia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
The recall was initiated because quality control (QC) results for the affected lots were outside of the expected ranges. This issue may affect the accuracy of the test results, which are intended to aid in monitoring patients previously treated for breast cancer or managing those with metastatic disease.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Cen
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 15,455
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)
- 86469198
- 85752198
- 88939198
- 87757198
- 85459198
- 88319198
- 86295198
- 85194198 ReadyPack¿ Lot Number Ending in 202: 93573202
- 91045202
- 93664202
- 90880202
- 93157202
- 91126202
- 85862199
- 86949199
- 85945199
Distribution
Distributed nationwide across the United States.
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