IMMULITE® 2000 Systems OV OM-MA (CA125) 10380972Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414961798), received between Aug 9, 2022 and Mar 24, 2026 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT ELEVATED OM-MA (OV) PATIENT RESULT WHEN USING KIT LOT 321 ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL INSTRUMENT, AND THE REPEAT RESULT WAS LOWER, AND REPORTED AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681026 ↗
• MalfunctionAug 9, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 XPI OM-MA (CA125) DILUTED RESULTS FOR A PATIENT SAMPLE COMPARED TO REPEAT DILUTED RESULTS USING THE SAME INSTRUMENT. THE INITIAL RESULT READ ABOVE ASSAY MEASURING RANGE (500 U/ML) AND ONBOARD DILUTIONS WERE PERFORMED THREE TIMES WITH THE SAME SAMPLE. DISCORDANT LOW RESULTS WERE OBSERVED WITH THE FIRST SET OF DILUTED SAMPLE RESULTS. THE INITIAL DILUTED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE 2000 XPI OM-MA (CA125) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195580 ↗