Elecsys AMH 07026714190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630940363), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS AMH (AMH) RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER WAS PERFORMING A QC INVESTIGATION FOR LOW BIAS OF THE AMH ASSAY. THE REPORTER USED OLD PROFICIENCY MATERIAL FOR REPEATS AND IT WAS CONFIRMED THAT THERE WAS A LOW BIAS. THE REPORTER THEN SENT OUT THE PATIENT SAMPLES TO A LABORATORY THAT USES A ROCHE ELECSYS ANALYZER FOR A SPLIT-SAMPLE ANALYSIS. PATIENT 1: THE INITIAL RESULT FROM THE ANALYZER WAS 6.83 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 11.61 NG/ML. PATIENT 2: THE INITIAL RESULT FROM THE ANALYZER WAS 12.1 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 35.3 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633181 ↗