Atellica IM CA 15-3 10995485Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414598123), received between May 14, 2021 and Oct 25, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER IDENTIFIED DISCORDANT (DEPRESSED) ATELLICA IM CA15-3, LOT 218, PATIENT SAMPLE RESULTS. THE DISCORDANCE WAS FOUND AFTER AN ISSUE WITH QUALITY CONTROL (QC) RESULTS WAS RESOLVED AND PATIENT SAMPLES WERE RETESTED WERE SUBSEQUENTLY RETESTED ON A DIFFERENT ATELLICA IM ANALYZER. THE INITIAL DEPRESSED PATIENT RESULTS WERE REPORTED, BUT NOT QUESTIONED BY PHYSICIAN(S). CORRECTED REPORTS WERE ISSUED FOR THE SAMPLES USING THE HIGHER RETEST RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539857 ↗
• MalfunctionMay 14, 2021Low Test Results; Low Test Results

  FALSELY LOW, ATELLICA IM CA 15-3 (CA 15-3) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO HIGHER RESULTS OBSERVED WHEN THE SAME SAMPLE WERE RE-TESTED ON ALTERNATE ATELLICA SYSTEMS. THE CUSTOMER'S QUALITY CONTROL (QC) RESULTS WERE OBSERVED TO BE OUT OF RANGE AT THE TIME OF THE INCIDENT. THE HIGHER REPEAT RESULTS FROM THE ALTERNATE ATELLICA SYSTEMS WERE REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ATELLICA IM CA 15-3 (CA 15-3) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826397 ↗
• MalfunctionMay 14, 2021High Test Results; High Test Results

  A FALSELY ELEVATED, ATELLICA IM CA 15-3 (CA 15-3) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT COMPARED TO A LOWER RESULT OBSERVED WHEN THE SAME SAMPLE WAS RE-TESTED AFTER ASSAY RECALIBRATION USING A NEW REAGENT READYPACK. THE CUSTOMER'S QUALITY CONTROL (QC) RESULTS WERE OBSERVED TO BE OUT OF RANGE AT THE TIME OF THE INCIDENT AND REPEAT TESTING WAS PERFORMED AFTER ACCEPTABLE QC RESULTS WERE OBTAINED. THE LOWER REPEAT RESULT WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ATELLICA IM CA 15-3 (CA 15-3) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826393 ↗
• MalfunctionMay 14, 2021Low Test Results; Low Test Results

  A FALSELY LOW, ATELLICA IM CA 15-3 (CA 15-3) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT COMPARED TO A HIGHER RESULT OBSERVED WHEN THE SAME SAMPLE WAS RE-TESTED AFTER ASSAY RECALIBRATION USING A NEW REAGENT READYPACK. THE CUSTOMER'S QUALITY CONTROL (QC) RESULTS WERE OBSERVED TO BE OUT OF RANGE AT THE TIME OF THE INCIDENT AND REPEAT TESTING WAS PERFORMED AFTER ACCEPTABLE QC RESULTS WERE OBTAINED. THE HIGHER REPEAT RESULT WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ATELLICA IM CA 15-3 (CA 15-3) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826379 ↗