IMMULITE® 2000 Systems IGF-I 11128543Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00630414601236), received between Jul 14, 2017 and Apr 20, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I PATIENT RESULTS WHEN USING LOT 345 ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE INITIAL INSTRUMENT, AND THE REPEAT RESULTS WERE HIGHER AND MATCHED THE CLINICAL PICTURE OF THE PATIENTS. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS 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 24931291 ↗
• MalfunctionOct 31, 2025Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 IGF-1 REAGENT (LOT 342). AFTER OBSERVING A QUALITY CONTROL (QC) NEGATIVE BIAS, THE CUSTOMER REPROCESSED THE PATIENT SAMPLES THE FOLLOWING DAY ON AN ALTERNATE IMMULITE 2000 XPI SYSTEM, AND THE IGF-1 RESULTS RECOVERED HIGHER. THE HIGHER IGF-1 RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437873 ↗
• MalfunctionSep 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED IGF-I (INSULIN-LIKE GROWTH FACTOR I) RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. 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 DEPRESSED IGF-I RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064700 ↗
• MalfunctionSep 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I (INSULIN-LIKE GROWTH FACTOR I) RESULTS OBTAINED ON EIGHT PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. FOR TWO OF THE PATIENT SAMPLE RESULTS, THE INITIAL RESULTS WERE ACCESSIBLE TO THE PATIENTS. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE ACCESSIBLE TO THE PHYSICIAN(S); HOWEVER, NO PHYSICIAN QUESTIONED THE RESULTS. FOR THE OTHER SIX PATIENT SAMPLE RESULTS, THE INITIAL RESULTS WERE NOT ACCESSIBLE TO THE PATIENTS AND WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A CORRECTION REPORT WAS ISSUED FOR TWO OF THE PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064685 ↗
• MalfunctionJun 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I PATIENT SAMPLE RESULTS OBTAINED ON AN IMMULITE 2000 XPI INSTRUMENT FOLLOWING A CONTROL FAILURE. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319867 ↗
• MalfunctionJun 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT (S/N: (B)(6)). THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT (S/N: (B)(6)). THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT, AND FOR 1 PATIENT SAMPLE A RECTIFIED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183649 ↗
• MalfunctionOct 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF THREE ERRONEOUS FALSELY DEPRESSED PATIENT RESULTS WITH INSULIN-LIKE GROWTH FACTOR I (IGF-I), LOT NUMBER: 317 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6). THE FALSELY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS AND WERE QUESTIONED. THE SAMPLES WERE REPROCESSED ON THE OTHER IMMULITE 2000 XPI ANALYZER AND ONE RESULT WAS CORRECTED SAMPLE: SAMPLE ID (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508144 ↗
• MalfunctionOct 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE 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 DEPRESSED IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493732 ↗
• MalfunctionSep 23, 2024Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED A FALSELY DEPRESSED INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULT WAS OBTAINED ON AN IMMULITE 2000 SYSTEM. THE SAMPLE WAS REPEATED ON THE SAME SYSTEM AND THE REPEAT RESULT, CONSIDERED CORRECT, WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS IGF-1 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281232 ↗
• MalfunctionJul 29, 2022Low Test Results; Low Test Results

  TWO FALSELY DEPRESSED INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE FALSELY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECTED RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135829 ↗
• MalfunctionOct 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CONTACTED SIEMENS TO REPORT OBSERVATIONS OF IMPRECISION WITH IMMULITE 2000 XPI GROWTH FACTOR-1 (IGF-1) THAT CAUSED DISCORDANCE BETWEEN INITIAL AND REPEAT TEST RESULTS. PATIENT SAMPLES WERE TESTED AND THE RESULTS WERE REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RETESTED ON THE SAME DAY AND RESULTS WERE LOWER. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565448 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367618 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367617 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367615 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367613 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367612 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367611 ↗
• MalfunctionMar 23, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367610 ↗
• MalfunctionMar 22, 2018Human Factors Issue; Human Factors Issue

  THE CUSTOMER INFORMED SIEMENS THAT PATIENT SAMPLES WERE RUN DAILY FOR INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) ON AN IMMULITE 2000 XPI INSTRUMENT AND A NON-SIEMENS INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DISCORDANT IMMULITE 2000 XPI RESULTS. THE PHYSICIAN(S) OBSERVED THAT LOWER RESULTS WERE OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO THE NON-SIEMENS METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN IGF-1 PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364105 ↗
• MalfunctionJul 14, 2017Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY LOW INSULIN-LIKE GROWTH FACTOR I (RE-STANDARDIZED) RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHEN USING REAGENT KIT LOT 116. DIFFERENT SAMPLES WERE TESTED EARLIER USING AN ALTERNATE PLATFORM, WHICH HAD RESULTED HIGHER ON (B)(6) 2016, WHILE THE RESULTS WERE SIMILAR TO THAT OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT FOR THE OTHER TWO REPEAT RUNS ((B)(6) 2016 AND (B)(6) 2017). THE RESULT OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT WAS NOT REPORTED TO THE PHYSICIAN(S). THE RESULTS OBTAINED ON THE ALTERNATE PLATFORM WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGF-1 (RE-STANDARDIZED) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715078 ↗
• MalfunctionJul 14, 2017Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY LOW INSULIN-LIKE GROWTH FACTOR I (RE-STANDARDIZED) RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHEN USING REAGENT KIT LOT 116. THE SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM, RESULTING HIGHER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGF-1 (RE-STANDARDIZED) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715060 ↗