Siemens ADVIA Centaur BR Assay Recalled for Potential Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.
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, and the hazard involves potential test interference without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,900 kits of the ADVIA Centaur BR assay (Cat No. 03896216, SMN 10334837). The product is an in vitro diagnostic test used for the quantitative serial determination of cancer antigen CA 27.29 in human serum. It is intended to aid in monitoring patients previously treated for Stage II or Stage III breast cancer and managing patients with metastatic disease.
The recall is issued because of the potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) assay when used on ADVIA Centaur Systems. This interference could affect the accuracy of the test results.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Brazil, Canada, Colombia, Cyprus, Japan, and Spain. All lot codes are included in this recall. Users should contact Siemens Healthcare Diagnostics for further instructions on how to handle the affected kits.
The recalled product
- Product
- Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 1,900
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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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