FDA Device recall Z-1748-2017
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…
- FDA Device
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of 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… by Siemens Healthcare Diagnostics, citing potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1748-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-08 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Reason
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Identifiers
| code_info | All lot codes |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1748-2017%22
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