ADVIA Centaur® CA 125 II 10315696Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · CA 125 - CENTAUR - RGT - 500 tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 21, 2018Class IITerminated
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Z-1486-2018 · Root cause: Other · Recall details · FDA record ↗
Other TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) devices
- ADVIA Centaur® CA 125II 10310443Siemens Healthcare Diagnostics Inc. · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)1 recall10 reports
- ARCHITECT 02K4529Abbott GmbH · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)8 reports
- Atellica IM CA 125II 10995482Siemens Healthcare Diagnostics Inc. · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)3 reports
- ARCHITECT 02K4539Abbott GmbH · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)3 reports
- Alinity 08P4920Abbott GmbH · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)2 reports
- Alinity 08P4930Abbott GmbH · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)2 reports
- Elecsys CA 125 II Assay 11776223161Roche Diagnostics GmbH · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)2 reports
- IMMULITE® 2000 Systems OV OM-MA (CA125) 10380972Siemens Healthcare Diagnostics Products Ltd · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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