IMMULITE® 2000 Systems PRL Prolactin 10381200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414961934), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCORDANT LOW PATIENT SAMPLE RESULTS WHEN USING IMMULITE 2000 PROLACTIN KIT LOT 418, IN COMPARISON TO REPEAT TESTING WITH KIT LOT 420. THE CUSTOMER INDICATED THAT THEY WERE OBSERVING HIGH SLOPES WITH KIT LOT 418 AND FAILED CALIBRATIONS, BUT REPORTED PATIENT RESULTS. THE CUSTOMER TESTED PATIENT SAMPLE RA WITH KIT LOT 418 WITH AN INITIAL RESULT OF 11.4 NG/ML. THIS WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. THE CUSTOMER SWITCHED TO KIT LOT 420 AND REPEATED THE SAME SAMPLE ON THE SAME INSTRUMENT ON LOT 420 AND THE RESULT WAS 22.4 NG/ML. A CORRECTED REPORT WAS NOT ISSUED 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 15945633 ↗