Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 — Class II medical device recall Z-0162-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2012-11-07, distributed nationwide. BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ran
| Recall number | Z-0162-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2012-09-11 |
| Classified | 2012-10-27 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2016-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, ES, JP, KR, MX, NZ, PE, SA |
| Quantity | 15,455 kits |
| Reason classes | potency |
| Model numbers | 01157807, 02419937, 03204829, 03896216, 09010686 |
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 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 and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill 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 for recall
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.