Elecsys CA 125 II Assay 11776223161Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630945795), received between Sep 25, 2024 and Nov 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Low Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 125 II (CA 125 II) ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 5.41 U/ML. THIS RESULT WAS REJECTED BY THE PHYSICIAN. A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 507.6 U/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 487.8 U/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621615 ↗MalfunctionSep 25, 2024High Test Results; High Test Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS CA 125 II ASSAY ON A COBAS E411 RACK. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN AS THEY WERE HIGHER THAN EXPECTED. THE SAMPLES WERE REPEATED AND THESE VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A CA 125 VALUE OF 974.9 U/ML AND IT REPEATED AS 676.2 U/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A CA 125 VALUE OF 22259 U/ML AND IT REPEATED AS 12714 U/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305700 ↗
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
- ADVIA Centaur® CA 125 II 10315696Siemens Healthcare Diagnostics Inc. · TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)1 recall0 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
- 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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