IMMULITE® 2000 Systems HCG 10381194Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00630414961149), received between Feb 24, 2020 and Jul 7, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 22, 2022Class IIOpen, Classified

   Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

   Z-1015-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF IMPRECISE HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS OBTAINED ON DILUTED PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT (S/N: (B)(6)). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE PATIENT SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AT OTHER DILUTION FACTORS AND/OR IN MULTIPLE REPLICATES AT THE SAME DILUTION FACTOR. IT IS UNKNOWN WHICH RESULT(S) ARE CORRECT. THE CUSTOMER ENTERED MULTIPLE RESULTS INTO THE PRISCA SYSTEM AND CALCULATED THE RISK OF TRISOMY 21 FOR EACH RESULT, AND THERE WAS NO SIGNIFICANT CHANGE IN THE RISK RATIO. THE PHYSICIAN EVALUATED THE RESULTS WITH THE PATIENT'S CLINICAL INFORMATION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420031 ↗
• MalfunctionJul 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THREE DAYS LATER. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702941 ↗
• MalfunctionAug 18, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS ON ONE PATIENT SAMPLE. THE SAMPLE WAS RETESTED ON THE SAME DAY USING THE SAME INSTRUMENT AND AN ALTERNATE METHOD (ATELLICA IM ANALYZER) AND RESULTS WERE LOWER. ON A DIFFERENT DAY, THE CUSTOMER RETESTED THE SAME SAMPLE WITH IMMULITE 2000 XPI HCG AND THE ALTERNATE METHOD AND ALL RESULTS WERE LOW. A NEW SAMPLE WAS DRAWN AND TESTED A FEW DAYS LATER WITH IMMULITE 2000 XPI HCG AND THE ALTERNATE METHOD AND RESULTS WERE LOW. THE INITIAL ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE LOWER REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252602 ↗
• MalfunctionAug 9, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT FOR A PATIENT SAMPLE COMPARED TO REPEAT RESULTS USING THE SAME INSTRUMENT AND AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 XPI HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195153 ↗
• MalfunctionJan 18, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE IMMULITE 2000 XPI INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND INSTRUMENT TO PERFORM REPEAT TESTING. THE CUSTOMER NOTED THAT REPEAT RESULTS WERE LOWER AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280501 ↗
• MalfunctionJan 18, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE IMMULITE 2000 XPI INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND INSTRUMENT TO PERFORM REPEAT TESTING. THE CUSTOMER NOTED THAT REPEAT RESULTS WERE LOWER AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280489 ↗
• MalfunctionJul 26, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT INITIAL HIGH RESULT ON A PATIENT SAMPLE USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY. THE INITIALLY HIGH RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING OF THE SAME SAMPLE AND THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM SYSTEM, ALL RESULTING LOWER. THE LOWER HCG RESULT FIT THE PATIENT'S CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225632 ↗
• MalfunctionJul 26, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT INITIAL HIGH RESULT ON A PATIENT SAMPLE USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY. THE INITIALLY HIGH RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING OF THE SAME SAMPLE, RESULTING LOWER. THE LOWER HCG RESULT FIT THE PATIENT'S CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225626 ↗
• MalfunctionJul 26, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT FOR A PATIENT SAMPLE COMPARED TO REPEAT RESULTS USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY, AND AN ALTERNATE METHOD. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 XPI HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225553 ↗
• MalfunctionJul 26, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS FOR A PATIENT SAMPLE COMPARED TO REPEAT RESULTS USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY, AN ALTERNATE METHOD AND THE CLINICAL PICTURE. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 XPI HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225551 ↗
• MalfunctionJul 26, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS FOR A PATIENT SAMPLE COMPARED TO REPEAT RESULTS USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY, AN ALTERNATE METHOD AND THE CLINICAL PICTURE. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 XPI HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225545 ↗
• MalfunctionJun 17, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED AN INITIAL HIGH RESULT ON A PATIENT SAMPLE USING THE IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED ON THE SAME INSTRUMENT (S/N: (B)(4)) AND ON THE ATELLICA IM ON THE SAME DAY, GENERATING LOWER RESULTS. THE LOWER HCG RESULT WAS ACCEPTED BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019091 ↗
• MalfunctionMar 31, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A REPEAT RESULT WAS PERFORMED LATER USING THE SAME IMMULITE 2000 XPI AND WAS CONSIDERED CORRECT. THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904459 ↗
• MalfunctionMar 31, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A REPEAT RESULT WAS PERFORMED LATER USING THE SAME IMMULITE 2000 XPI AND WAS CONSIDERED CORRECT. THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904454 ↗
• MalfunctionFeb 24, 2020Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). TWO REPEAT RESULTS WERE PERFORMED USING ALTERNATE IMMULITE 2000 XPI AND WERE CONSIDERED CORRECT. ONE OF THE CORRECT RESULTS WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748506 ↗
• MalfunctionFeb 24, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WAS OBTAINED USING IMMULITE 2000 XPI. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THREE REPEAT RESULTS WERE PERFORMED USING ALTERNATE IMMULITE 2000 XPI AND WERE CONSIDERED CORRECT. ONE OF THE CORRECT RESULTS WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748504 ↗