Siemens ADVIA Centaur BR Assay Recalled for Potential Syphilis Assay Interference
Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.
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 assay interference affecting diagnostic accuracy, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,259 kits of the ADVIA Centaur BR assay (Cat No. 09010686, SMN 10340081). The recall is issued because of a potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) assay on ADVIA Centaur Systems.
The affected 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 covers all lot codes.
The product was distributed worldwide, including nationwide in the United States and internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, and Spain. Users of the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 1,259
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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