Elecsys FSH 11775863122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630909223), received between Jul 15, 2025 and Jan 8, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FSH ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS <0.300 MIU/ML. THE REPEAT RESULT WAS 6.80 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005335 ↗
• MalfunctionJul 15, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III) AND ELECSYS FSH (FSH) ON A COBAS 6000 E601 MODULE. THE ESTRADIOL III RESULT FROM THE E601 MODULE WAS 769.20 PMOL/L. THE SAMPLE WAS REPEATED TWICE ON THE E601 MODULE WITH RESULTS OF 800.8 PMOL/L AND 804.6 PMOL/L. THE FSH RESULT FROM THE E601 MODULE WAS 1.31 IU/L. THE DOCTOR QUESTIONED THE ESTRADIOL RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S CONDITION. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD, AND THE ESTRADIOL RESULT WAS < 55.1 PMOL/, L AND THE FSH RESULT WAS 1.85 MIU/ML. THIS MEDWATCH WILL COVER FSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506720 ↗