Atellica IM CA 125II 10995482Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414598093), received between Aug 24, 2023 and Aug 8, 2024 — 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.

• MalfunctionAug 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANCE BETWEEN RESULTS FROM NEAT (UNDILUTED) AND DILUTED SAMPLES WHEN RUNNING ATELLICA IM CA 125II (CA 125II), LOT 218. DISCORDANCE WAS OBSERVED AMONG RESULTS FOR A 90-YEAR-OLD FEMALE PATIENT WITH OVARIAN CANCER. A CA 125II RESULT VERY NEAR THE UPPER END OF THE ASSAY¿S MEASURING INTERVAL WAS OBTAINED FOR THE PATIENT IN QUESTION. WHEN THE SAMPLE WAS REPEAT-TESTED, A RESULT OF 600 IU/ML (TOP OF MEASURING RANGE) WAS OBTAINED. THE SAME SAMPLE WAS RE-TESTED FOLLOWING 20-FOLD DILUTION, AND A MUCH HIGHER RESULT (~+60%) WAS OBSERVED. WHEN THIS SAMPLE WAS REPEATED AGAIN FOLLOWING 10-FOLD DILUTION, A SIMILAR HIGH RESULT WAS PRODUCED. THESE HIGHER RESULTS WERE INCONSISTENT WITH THE INITIAL RESULT AS WELL AS THE PATIENT¿S RECENT TESTING IN JUNE, 2024. TO INVESTIGATE THIS INCONSISTENCY, AN EARLIER SAMPLE (JUNE) FROM THE SAME PATIENT, WHICH HAD INITIALLY PRODUCED A RESULT NEAR 600 IU/ML, WAS REPEAT-TESTED FOLLOWING DILUTION. THIS SAMPLE ALSO PRODUCED A HIGHER RESULT (NEAR 900 IU/ML) WHEN RE-TESTED FOLLOWING 10-FOLD DILUTION. THE SAMPLE FROM JUNE WAS SENT TO AN EXTERNAL LAB FOR TESTING BY AN ALTERNATE METHOD. THE ALTERNATE-METHOD RESULT WAS CLOSER TO THE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938874 ↗
• MalfunctionAug 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ELEVATED CA 125II PATIENT SAMPLE RESULT BY DILUTION ON ATELLICA IM ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). ANOTHER SAMPLE FROM THE SAME PATIENT WAS MEASURED ON AN ALTERNATE ATELLICA IM ANALYZER ON A DIFFERENT DATE AND THE RESULT WAS LOWER, WHICH WAS CONSIDERED AS DISCORDANT. BOTH THE SAMPLES WERE REMEASURED ON THIS ALTERNATE ATELLICA IM ANALYZER ON ANOTHER DATE, AND THE DILUTED AND NON-DILUTED RESULTS OBTAINED WERE COMPARABLE WITH THE DISCORDANT LOWER RESULT. THE ELEVATED RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125II LOWER RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611822 ↗
• MalfunctionAug 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ELEVATED CA 125II PATIENT SAMPLE RESULT BY DILUTION ON ATELLICA IM ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). ANOTHER SAMPLE FROM THE SAME PATIENT WAS MEASURED ON AN ALTERNATE ATELLICA IM ANALYZER ON A DIFFERENT DATE AND THE RESULT WAS LOWER, WHICH WAS CONSIDERED AS DISCORDANT. BOTH THE SAMPLES WERE REMEASURED ON THIS ALTERNATE ATELLICA IM ANALYZER ON ANOTHER DATE, AND THE DILUTED AND NON-DILUTED RESULTS OBTAINED WERE COMPARABLE WITH THE DISCORDANT LOWER RESULT. THE ELEVATED RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125II LOWER RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611811 ↗