Class II — Siemens Healthcare Diagnostics, Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. |
| 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 … |
| Quantity | 15,455 kits |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain. |
| Initiated | 2012-09-11 |
| Classified | 2012-10-27 |
| Terminated | 2016-09-01 |
| Recall number | Z-0162-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc (Z-0162-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63167/
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