Atellica IM CA 15-3 10995486Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414598130), received between May 14, 2021 and Nov 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CA 15-3 RESULT WHICH WAS DISCORDANT RELATIVE TO PATIENT HISTORY. THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM CA 15-3 RESULT FOR A 33-YEAR-OLD FEMALE PATIENT WHICH WAS CONSIDERED INCONSISTENT WITH PATIENT HISTORY, AND NOT REPORTED TO THE PHYSICIAN. THE RESULT WAS CONSIDERED FALSELY ELEVATED, AS THE SAME PATIENT SAMPLE HAD PREVIOUSLY PRODUCED A LOWER RESULT WHEN TESTED EARLIER USING THE SAME METHOD. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890941 ↗
• MalfunctionAug 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED CA15-3 RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER (SERIAL NO. (B)(4)). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE ORIGINAL SAMPLES WERE REPEATED EITHER ON THE SAME INSTRUMENT OR AN ALTERNATE INSTRUMENT . THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CA15-3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339694 ↗
• MalfunctionMay 14, 2021Low Test Results; Low Test Results

  FALSELY LOW, ATELLICA IM CA 15-3 (CA 15-3) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO HIGHER RESULTS OBSERVED WHEN THE SAME SAMPLE WERE RE-TESTED ON ALTERNATE ATELLICA SYSTEMS WITH DIFFERENT REAGENT READYPACKS FROM THE SAME REAGENT LOT NUMBER. 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 11826394 ↗