Elecsys Testosterone II 08946353190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336170557), received between Jun 23, 2023 and Feb 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN A TESTOSTERONE VALUE OF 7.36 NG/DL. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 347.8 NG/DL AND 351.3 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344096 ↗
• MalfunctionDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE, COBAS E 801 ANALYZER, AND A COMPETITOR ANALYZER. THE INITIAL RESULT WAS 2.38 NG/ML. ANOTHER SAMPLE COLLECTED FROM THE PATIENT ON THE SAME DAY WAS TESTED AND THE RESULT WAS 2.50 NG/ML. THE FIRST SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON AN E801 ANALYZER AND THE RESULT WAS 2.31 NG/ML. ALL OF THE RESULTS WERE ABOVE THE ROCHE NORMAL FEMALE REFERENCE RANGE. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE INCONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION. THE FIRST SAMPLE WAS TESTED ON A BECKMAN ANALYZER AND THE RESULT WAS 0.363 NG/ML, WHICH WAS WITHIN THE NORMAL BECKMAN REFERENCE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839073 ↗
• MalfunctionMay 23, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULT FROM THE COBAS 6000 E601 MODULE. THE AFFECTED PATIENT ALSO HAD QUESTIONABLE ESTRADIOL RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS TESTOSTERONE II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ESTRADIOL III ASSAY. THE INITIAL RESULT WAS 1061 NG/DL, AND THE 1ST REPEAT RESULT WAS 1073 NG/DL. A 2ND REPEAT RESULT FROM THE SAME INITIAL DRAW, BUT A NEW SAMPLE TUBE WAS 1113 NG/DL. A RESULT FROM A NEW SAMPLE FROM THE SAME PATIENT WAS 192.3 NG/DL. THE RESULT OF 192.3 NG/DL WAS DEEMED TO BE CORRECT. THE INITIAL RESULT WAS QUESTIONED BY THE CARE PROVIDER AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THEY ORDERED A NEW SAMPLE TO BE DRAWN FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080015 ↗
• MalfunctionMay 7, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 11.6 NMOL/L. THE REPEAT RESULT WAS 1.2 NMOL/L. THE SAMPLE WAS REPEATED AT ANOTHER SITE BY AN UNSPECIFIED METHOD, AND THE LOW RESULT WAS CONFIRMED. THE ACTUAL RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975783 ↗
• MalfunctionNov 17, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TESTOSTERONE G2 ELECSYS RESULTS FROM THE COBAS E411 RACK ANALYZER. PATIENT 1 INITIAL RESULT WAS >1500 NG/DL AND THE REPEAT RESULTS WERE 69.83 NG/DL AND 46.45 NG/DL. THE REPEAT RESULTS ON ANOTHER ANALYZER WERE 28.62 NG/DL AND 33.47 NG/DL. PATIENT 2 INITIAL RESULT WAS 177.5 NG/DL AND THE REPEAT RESULTS WERE 46.47 NG/DL AND 109.8 NG/DL. THE REPEAT RESULTS ON ANOTHER ANALYZER WERE 38.24 NG/DL AND 39.83 NG/DL. THE RESULTS FROM THE OTHER ANALYZER WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165696 ↗
• MalfunctionJun 23, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT WAS 52.05 NMOL/L WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE AND REQUESTED REPEAT TESTING. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 8.21 NMOL/L AND 7.91 NMOL/L. THE E602 MODULE SERIAL NUMBER WAS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195029 ↗