IMMULITE®/IMMULITE® 1000 Systems HCG 10381161Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414963716), received between Feb 14, 2023 and Apr 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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.

• MalfunctionApr 10, 2024High Test Results; High Test Results

  A FALSELY ELEVATED HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 1000 INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED USING AN ALTERNATE PLATFORM. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND WAS IN ALIGNMENT WITH THE CLINICAL PICTURE OF THE PATIENT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED ERRONEOUS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080965 ↗
• MalfunctionApr 10, 2024High Test Results; High Test Results

  A FALSELY ELEVATED HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 1000 INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED USING AN ALTERNATE PLATFORM. THE REPEAT RESULT WAS NEGATIVE AND WAS IN ALIGNMENT WITH THE CLINICAL PICTURE OF THE PATIENT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED ERRONEOUS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080955 ↗
• MalfunctionFeb 14, 2023High Test Results; High Test Results

  THE CUSTOMER INDICATED THERE WAS A DISCREPANT RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 1000 ANALYZER, SERIAL NUMBER (B)(4), WHEN USING IMMULITE 1000 HUMAN CHORIONIC GONADOTROPIN (HCG) REAGENT LOT 511. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371136 ↗