Elecsys FSH 08932352190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336170373), received between Dec 5, 2024 and Apr 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FSH RESULTS FROM THE COBAS E411 DISK ANALYZER. PATIENT 1 INITIAL RESULT WAS < 0.300 MIU/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 36.25 MIU/ML. PATIENT 2 INITIAL RESULT WAS < 0.300 MIU/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 7.5 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956933 ↗
• MalfunctionSep 19, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS AFP ASSAY AND 1 PATIENT SAMPLE TESTED WITH ELECSYS FSH ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). THIS MEDWATCH WILL APPLY TO THE FSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE AFP ASSAY. PATIENT 1: AFP: INITIAL RESULT: 0.750 IU/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 51.95 IU/ML. PATIENT 2 WAS TESTED ON (B)(6) 2025: FSH: INITIAL RESULT: 0.300 MIU/ML. REPEAT RESULT: 6.20 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096281 ↗
• MalfunctionMay 27, 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 FOLLICLE STIMULATING HORMONE (FSH) ASSAY ON A COBAS 6000 CORE UNIT. INITIAL RESULT: 7.52 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. REPEAT RESULT: 19.10 MIU/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086907 ↗
• MalfunctionDec 5, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FSH ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (DISK SYSTEM). AN INTERFERENCE WITH AUTOANTIBODIES IS SUSPECTED. THE INITIAL RESULT WAS 64.7 MIU/ML. THE RESULT USING THE CLIA METHOD WAS 21.7 MIU/ML. THE RESULT USING THE ABBOTT METHOD WAS 21.1 MIU/ML. ON (B)(6) 2024 THE SAMPLE WAS TESTED ON ANOTHER MODULE USING THE ELECSYS FSH ASSAY AND THE RESULT WAS 67.78 MIU/ML. IT WAS REPORTED THAT PEG (POLYETHYLENE GLYCOL) PRECIPITATION TESTING WAS PERFORMED WITH THE SAMPLE ON ANOTHER MODULE AND THE "RECOVERY RATE OF FSH WAS SIGNIFICANTLY REDUCED, AND AUTOIMMUNE IG-FSH COMPLEXES ("MACRO-FSH") WERE IDENTIFIED BY GEL FILTRATION CHROMATOGRAPHY". ANOTHER PEG (POLYETHYLENE GLYCOL) PRECIPITATION TEST WAS PERFORMED ON THE SAMPLE USING THE ABBOTT METHOD AND "THE RECOVERY RATE OF FSH DROPPED SIGNIFICANTLY.". THE NUMERICAL VALUES FROM THE PEG TESTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853800 ↗