Elecsys IGF-1 07475918190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336140864), received between Oct 5, 2022 and Aug 7, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175662 ↗
• MalfunctionNov 3, 2025Output Problem; Output Problem

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS IGF-1 (IGF-1) STARTING AT THE BEGINNING OF (B)(6) 2025 ON A COBAS 8000 E 801 MODULE. THE CUSTOMER HAD PREVIOUSLY USED THE IMMULITE INSTRUMENT, AND THE IGF-1 RESULTS WERE LOWER. AN EXAMPLE OF QUESTIONABLE RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. ON (B)(6) 2025, THE RESULT FROM THE SIEMENS METHOD WAS 706.0 NG/ML. ON (B)(6) 2025, THE RESULT FROM THE E801 MODULE WAS 1107 NG/ML. THE REPEAT RESULT WAS 1153 NG/ML. THE PATIENT HAD A PREVIOUS RESULT (B)(6) 2025) FROM THE IMMULITE INSTRUMENT OF 673 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450187 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS IGF-1 ASSAY ON A COBAS 8000 CORE UNIT. INITIAL RESULT: 1232 NG/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 940 NG/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT AND REPORTED TO THE CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920613 ↗
• MalfunctionNov 4, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGF-1 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO A SIEMENS IMMULITE. ON (B)(6) 2022, THE IGF-1 RESULT WAS 89 NMOL/L. ON (B)(6) 2022, THE SIEMENS IGF-1 RESULT WAS 60 NMOL/L. THE EXACT DATE OF TESTING WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2022, THE SAMPLE WAS REPEATED ON THE E801 MODULE AND THE RESULT WAS 94 NMOL/L. THE ROCHE REFERENCE RANGE IS 15 - 64 NMOL/L. THE SIEMENS REFERENCE RANGE IS 23 - 66 NMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 MODULE SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729514 ↗
• MalfunctionOct 5, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW IGF-1 ELECSYS RESULTS FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4) THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENTS. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 80.2 NG/ML AND A REPEAT RESULT OF 149 NG/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. THE REPEAT RESULTS FIT THE PATIENTS' HISTORIES AND WERE CONSIDERED VALID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544191 ↗