Elecsys IGF-1 07475896190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613336143131), received between Dec 3, 2021 and Mar 4, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF DISCREPANCIES BETWEEN THE ELECSYS IGF-1 MEASUREMENTS FROM THE COBAS E411 ANALYZER WHEN COMPARED WITH THE RESULTS FROM AN IMMULITE 2000XPI SIEMENS HEALTHCARE DIAGNOSTICS ANALYZER, AND WHEN CORRELATED WITH THE CLINICAL COURSE OF SEVERAL PATIENTS FROM A JOURNAL ARTICLE "BEYOND THE METHOD CHANGE IN CLINICAL PRACTICE: EVALUATION OF INSULIN-LIKE GROWTH FACTOR I ASSAY" BY PAULA SIENES BAILO, MARTA FABRE ESTREMERA, JOSÉ CUENCA ALCOCEL, AND MARÍA ÁNGELES CÉSAR MÁRQUEZ, PUBLISHED ONLINE ON 23-AUG 2022. THE JOURNAL ARTICLE IS ATTACHED TO THIS MEDWATCH. THE JOURNAL STATED THAT WITHIN MONTHS AFTER A LABORATORY CHANGED THEIR ASSAY FROM THE IMMULITE 2000XPI, WITH AN ENZYME-LABELLED CHEMILUMINESCENT IMMUNOMETRIC ASSAY LABORATORY METHOD TO THE COBAS E411 WITH AN ELECTROCHEMILUMINESCENCE IMMUNOASSAY LABORATORY METHOD, THEY HAVE OBSERVED A SUSPICIOUSLY HIGH PROPORTION OF SAMPLES WITH IGF-1 CONCENTRATIONS ABOVE THE AGE- AND SEX-SPECIFIC REFERENCE INTERVALS (RIS) PROVIDED BY THE ROCHE DIAGNOSTICS AND THAT CLINICIANS ALSO OBSERVED DISCREPANCIES BETWEEN IGF-1 MEASUREMENTS BY COBAS E411 AND THE CLINICAL COURSE OF SEVERAL PATIENTS; THE IGF-1 RESULTS MEASURED BY THE COBAS E411 W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507783 ↗
• MalfunctionMar 2, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IGF-1 ASSAY RESULTS FROM EIGHT PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE REPORTER STATED THAT CLINICIANS ARE QUESTIONING THE ELECSYS IGF-1 RESULTS OBTAINED FROM THE ANALYZER, AS THEY ARE HIGHER THAN THOSE FROM THE IMMULITE ANALYZER. THE FOLLOWING ARE REPRESENTATIVE EXAMPLES OF TWO PATIENT SAMPLES WITH DISCREPANT RESULTS FROM THE LIST OF EIGHT PATIENT SAMPLES PROVIDED: PATIENT SAMPLE 1. THE RESULT FROM THE ANALYZER IS 492 UG/L. THE RESULT FROM THE IMMULITE ANALYZER IS 342 UG/L. PATIENT SAMPLE 2. THE RESULT FROM THE ANALYZER IS 603 UG/L. THE RESULT FROM THE IMMULITE ANALYZER IS 456 UG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24486886 ↗
• MalfunctionMar 21, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS IGF-1 RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1600 NG/ML. THE FOLLOWING ARE THE RESULTS AFTER DILUTION: A DILUTION OF 1:10 WITH A RESULT OF 1157 NG/ML. A DILUTION OF 1:5 WITH A RESULT OF 1198 NG/ML. A DILUTION OF 1:2 WITH A RESULT OF 1143 NG/ML. A MANUAL DILUTION OF 1:10 WITH A RESULT OF 1153 NG/ML. A MANUAL DILUTION OF 1:5 WITH A RESULT OF 1170 NG/ML THERE WAS A PRECIPITATION RESULT OF 1243 NG/ML. THEY COMPARED THE RESULTS TO A SIMENS ANALYZER WITH A RESULT OF 640 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663127 ↗
• MalfunctionFeb 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IGF-1 ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. ON (B)(6) 2024: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 103.6 NG/ML. ON (B)(6) 2024: THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 80.1 NG/ML. ON (B)(6) 2024: THE SECOND REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 81.5 NG/ML. THE THIRD REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 96.90 NG/ML. THIS RESULT WAS DEEMED LOW AND WAS DISPUTED BY THE DOCTOR. THE PATIENT SAMPLE WAS SENT TO A SUBCONTRACTOR LABORATORY THAT USES EUROIMMUN AND IMMULITE 2000 XPI ANALYZERS. BOTH ANALYZERS USE THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) LABORATORY METHOD. THE FOURTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE EUROIMMUN ANALYZER WAS 488.2 NG/ML. THE FIFTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM AN IMMULITE 2000 XPI ANALYZER WAS 381.00 NG/ML. THE REPEAT RESULTS USING THE CLIA METHOD CORRELATED WITH THE PATIENT'S CLINICAL CONDITION. ON (B)(6) 2024: THE SIXTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 129.6 NG/ML. THE SEVENTH RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809659 ↗
• InjuryDec 7, 2022Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; High Test Results; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; High Test Results

  WE RECEIVED AN ALLEGATION THAT THE ELECSYS IGFBP-3 ASSAY AND ELECSYS IGF-1 ASSAY RESULTS MAY HAVE CONTRIBUTED TO A NEGATIVE IMPACT ON PATIENTS' GROWTH AND THE PATIENTS WERE REPORTEDLY NOT PROGRESSING AS EXPECTED. THIS MDR IS FOR THE IGF-1 ASSAY. REFER TO PATIENT IDENTIFIER: (B)(6) FOR THE IGFBP-3 ASSAY. THE REPORTER STATED THAT PEDIATRIC ENDOCRINOLOGISTS HAVE RAISED A CONCERN ABOUT THE IGF-1 AND IGFBP3 RESULTS. THEY REPORTEDLY NOTICED THAT THE VALUES HAVE BEEN HIGHER THAN THE PREVIOUS METHOD (THE IMMULITE) AND HAVE BEEN REPORTEDLY TREATING THEIR PATIENTS BASED ON THE HIGHER RESULTS. THE REPORTER STATED THAT DURING VALIDATION PRIOR TO CHANGING TO THE ROCHE METHOD, THE E411 WAS REPORTEDLY RUNNING HIGHER THAN THE IMMULITE. MOST SAMPLES REPORTEDLY STAYED WITHIN OR OUTSIDE OF THE REFERENCE RANGE. THE REPORTER STATED THAT THEY THOUGHT THAT THE PREVIOUS SYSTEM WAS TOO LOW, NOT THAT THE ROCHE WAS TOO HIGH. THE REPORTER STATED THEY HAD CHANGED THE REFERENCE RANGE TO REFLECT THE ROCHE REFERENCE RANGE. THIS REPORTEDLY HAD INCREASED SLIGHTLY FROM THE PREVIOUS METHODOLOGY. THE REPORTER WENT ON TO STATE THAT AFTER THE PHYSICIANS TREATED THEIR PATIENTS BASED ON ROCHE'S RESULTS, THEY SAW A NEGATIV

  Patient problems: Hormonal Imbalance; Insufficient Information

  MAUDE report 15933850 ↗
• MalfunctionJul 27, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IGF-1 RESULTS FOR 18 PATIENTS TESTED WITH A COBAS E411 DISK. BASED ON THE PROVIDED DATA, THE IGF RESULTS FOR SIX PATIENTS WERE DISCREPANT. PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMS THAT CALIBRATION AND QC HAVE BEEN ACCEPTABLE. THE ELECSYS IGF RESULTS WERE REPORTED OUTSIDE THE LABORATORY. DUE TO THE RESULTS NOT MATCHING THE CLINICAL PICTURE OF THE PATIENTS, THE PATIENTS HAVE A NEW SAMPLE COLLECTED AND TESTED AT A DIFFERENT LABORATORY AND WITH A SIEMENS IMMULITE 2000. THE CUSTOMER DETERMINED THE SIEMENS RESULTS WERE CORRECT. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 204.8 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 149 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 699.5 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 517 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 553.3 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 411 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 395.4 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 297 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 858.5 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 607 N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117092 ↗
• MalfunctionDec 3, 2021High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED RESULTS TESTED FOR IGF-1 ELECSYS COBAS E 100 (IGF-1) ON A COBAS E 411 IMMUNOASSAY ANALYZER. A PHYSICIAN QUESTIONED RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES NOT MATCHING THEIR CLINICAL PICTURE. IT WAS NOTED THAT THIS WAS ONLY OBSERVED WITH PATIENTS BEING SUPPLEMENTED BY GROWTH HORMONES. SIX PATIENT SAMPLES WERE TESTED ON THE E411 ANALYZER AND THE IMMULITE ANALYZER. OF THE 6 SAMPLES, THE RESULTS FOR 4 PATIENT SAMPLES WERE EITHER DISCREPANT WHEN COMPARED TO THE IMMULITE OR THE RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION AS DETERMINED BY THE REFERENCE RANGES FOR THE RESPECTIVE ASSAYS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS, GENDER AND AGE. THE PHYSICIAN BELIEVED THE RESULTS FROM THE IMMULITE ANALYZER TO BE CORRECT. THE QUESTIONABLE RESULTS FROM THE E411 ANALYZER WERE REPORTED OUTSIDE OF THE LABORATORY. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923342 ↗