Elecsys CEA Assay 11731629160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630938766), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT ELECSYS CEA ASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). FOR PATIENT 1 THE INITIAL CEA RESULT WAS 36.2 NG/ML AND THE REPEAT RESULT WAS 25.6 NG/ML ON THE E 411. THE SAMPLE WAS SENT TO A DIFFERENT LABORATORY. THE CEA RESULT WAS 63.5 NG/ML ON THE ABBOTT ARCHITECT INSTRUMENT AND WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018, THE CUSTOMER CHANGED THE REAGENT PACK AND RECALIBRATED. THE SAMPLE WAS REPEATED AND THE CEA RESULTS WERE 50.9 NG/ML AND 50.7 NG/ML. FOR PATIENT 2 ON (B)(6) 2018, THE INITIAL CEA RESULT WAS 90 NG/ML AND THE REPEAT RESULT WAS 70 NG/ML ON THE E 411. THE CEA RESULT WAS 200 NG/ML IN A DIFFERENT LABORATORY WITH THE ABBOTT ARCHITECT. FOR PATIENT 3 ON (B)(6) 2018, THE INITIAL CEA RESULT WAS 89 NG/ML AND THE REPEAT RESULT WAS 90 NG/ML ON THE E 411. THE CEA RESULT WAS 400 NG/ML IN A DIFFERENT LABORATORY WITH THE ABBOTT ARCHITECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE FIELD SERVICE ENGINEER(FSE) RAN A PERFORMANCE TEST THAT FAILED. THE FSE PERFORMED AN ADJUSTMENT AND AN INITIAL CELL BLANK. THE CALIBRATION AND QC WERE ACCEPTAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818983 ↗