Atellica IM CA 125II 10995481Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414598086), received between Jun 3, 2021 and Jun 20, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A BIAS IN ATELLICA IM CA 125II PATIENT RESULTS BETWEEN REAGENT LOT 223 AND 221. THIS WAS IDENTIFIED WHEN THE CUSTOMER WAS PERFORMING LOT TO LOT COMPARISONS AS PART OF THEIR LAB PROCESS WHEN CHANGING REAGENT LOTS (FROM LOT 221 TO LOT 223). THE CUSTOMER STATES THAT QUALITY CONTROL (QC) WAS IN RANGE AND NO PATIENTS GENERATED WITH LOT 221 WERE QUESTIONED BY PHYSICIANS; THERE IS NO INDICATION THAT ERRONEOUS RESULTS CA125II PATIENT RESULTS WERE REPORTED. 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 22302080 ↗
• MalfunctionJun 3, 2021Low Test Results; Low Test Results

  A DISCORDANT LOW ATELLICA IM CA 125II (CA 125II) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER WHEN PERFORMING A ROUTINE QUALITY CONTROL (QC) CHECK OBSERVED AN OUT OF RANGE LOW QC RESULT THAT REQUIRED AN ASSAY RECALIBRATION TO RESOLVE. THE CUSTOMER PERFORMED REPEATED TESTING ON THE ONLY PATIENT SAMPLE THAT WAS RUN PRIOR TO THE ROUTINE QC CHECK. THE PATIENT SAMPLE WHEN REPEATED RESULTED HIGHER. THE HIGHER CA 125II WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ATELLICA IM CA 125II RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930989 ↗