Elecsys CA 15-3 II 07027001190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630939961), received between Mar 17, 2023 and Mar 17, 2023 — classified as 1 malfunction.

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.

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.

• MalfunctionMar 17, 2023Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE DOCTOR BELIEVED THE RESULTS DID NOT MATCH THE MEDICAL IMAGING RESULTS AND QUESTIONED IF THERE WERE INTERFERING SUBSTANCES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. REFER TO THE MEDWATCHES WITH THE FOLLOWING A1 PATIENT IDENTIFIERS FOR ALL INVOLVED ASSAYS: (B)(6) FOR THE CA 15-3 ASSAY. (B)(6) FOR THE CEA ASSAY. (B)(6) FOR THE CYFRA 21-1 ASSAY. (B)(6) FOR THE CA19-9 ASSAY. (B)(6) FOR THE CA 125 ASSAY. (B)(6) FOR THE AFP ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566989 ↗