Elecsys Testosterone IIRecalls & reported problems across all models

We found 4 models of Elecsys Testosterone II by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2018 and Apr 14, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Testosterone II problems

Elecsys Testosterone II models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Testosterone II 08946370190

  RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
  19 reports
• Elecsys Testosterone II 08946353190

  RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
  6 reports
• Elecsys Testosterone II 07027915190

  RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
  4 reports
• Elecsys Testosterone II 05200067160

  RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
  1 report

Recent Elecsys Testosterone II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II), ELECSYS ESTRADIOL III (ESTRADIOL III), AND ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE SIEMENS METHOD AND LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS). THIS MEDWATCH WILL COVER TESTOSTERONE II. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE PROLACTIN II RESULTS. THE TESTOSTERONE II RESULT FROM THE E801 ANALYZER WAS 52.0 NMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 25 NMOL/L. THE LC-MS RESULT WAS 17.7 NMOL/L. THE ESTRADIOL III RESULT FROM THE E801 ANALYZER WAS 474 PMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.16 PMOL/L. THE PROLACTIN II RESULT FROM THE E801 ANALYZER WAS 265 MU/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.17 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877022 ↗
• MalfunctionMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TESTOSTERONE VALUE OF 46 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF 40.5 NMOL/L. THE SAMPLE WAS TESTED ON A COMPETITOR SYSTEM (ABBOTT ALINITY) AND IT RESULTED IN A TESTOSTERONE VALUE OF 10.3 NMOL/L. THE SAMPLE WAS ALSO TESTED USING THE LC-MS/MS METHOD, RESULTING IN A TESTOSTERONE VALUE OF 12.3 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616337 ↗
• 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 ↗
• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TESTOSTERONE II ON A COBAS E 801 ANALYTICAL UNIT WHEN COMPARED TO ABBOTT. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: FEMALE, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184135 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TESTOSTERONE II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866556 ↗
• 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 ↗
• MalfunctionDec 15, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <2.5 NMOL/L. THE PHYSICIAN QUESTIONED THE RESULT, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULT WAS 6.24 NMOL/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23808625 ↗
• MalfunctionDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 801 MODULE. INITIAL RESULT: 30.4 NMOL/L. ON (B)(6) 2025: REPEAT RESULT: 19.12 NMOL/L (TESTED USING BECKMAN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686682 ↗
• MalfunctionNov 11, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY AND ELECSYS ESTRADIOL III RESULTS FOR ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ELECSYS TESTOSTERONE II ASSAY. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS ESTRADIOL III ASSAY. THE PATIENT HAD BEEN CONTINUOUSLY MONITORED FOR OVER THREE MONTHS AND HAD CONSISTENTLY ELEVATED RESULTS FROM THREE E 801 ANALYZERS. THE PATIENT WENT TO ANOTHER HOSPITAL FOR TESTING AND REPORTED TO THE CLINICIAN THAT THE RESULTS FROM A SIEMENS ANALYZER WERE NORMAL. ON (B)(6) 2025, THE PATIENT HAD NEW SAMPLES COLLECTED. THE TESTOSTERONE RESULT FROM THE ANALYZER WAS 3.39 NMOL/L. THE TESTOSTERONE RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 1.401 NMOL/L. THE ESTRADIOL RESULT FROM THE ANALYZER WAS 2444 PMOL/L. THE ESTRADIOL RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 896 PMOL/L. THE MASS SPECTROMETRY RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE REPORTER SUSPECTS AN INTERFERENT IN THE PATIENT'S SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524601 ↗
• MalfunctionOct 22, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.76 NMOL/L. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS 0.45 NMOL/L. THE INITIAL RESULT WAS INCONSISTENT WITH THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359036 ↗
• MalfunctionOct 15, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.05 NG/ML. THE RESULT WAS QUESTIONED BECAUSE IT SEEMED UNEXPECTEDLY HIGH. THE SAMPLE WAS TESTED USING ANOTHER METHOD (SIEMENS), AND THE REPEATED RESULT WAS 0.561 NG/ML. THE CLINICIAN BELIEVES THE REPEATED RESULT IS MORE ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294200 ↗
• MalfunctionAug 12, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 801 MODULE. THE PATIENT'S SAMPLE RESULTED IN A TESTOSTERONE VALUE OF > 52.0 NMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING AS > 52.0 NMOL/L. THE CLINICIAN SUSPECTED THAT THE TESTOSTERONE RESULTS WERE INCONSISTENT WITH PREVIOUS VALUES. THE SAMPLE WAS REPEATED TWICE USING THE BECKMAN PLATFORM, RESULTING IN TESTOSTERONE VALUES OF 5.97 NG/ML (21.9 NMOL/L) AND 20.7 NMOL/L (REFERENCE RANGE = 6.07 TO 27.1 NMOL/L).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782531 ↗
• MalfunctionJul 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TESTOSTERONE G2 (TESTOSTERONE II) ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE WAS TESTED ON SIEMENS, AND THE RESULT WAS 897 NG/DL. THE ORIGINAL SAMPLE WAS TESTED ON AN E801, AND THE RESULT WAS 1500 NG/DL (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED TWICE ON E801, AND THE REPEAT RESULTS WERE BOTH 1500 NG/DL (ACCOMPANIED BY DATA FLAGS). ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED ON SIEMENS, AND THE REPEAT RESULT WAS 897 NG/DL. THE SAMPLE WAS THEN REPEATED ON SIEMENS USING A DIFFERENT MODULE, AND THE REPEAT RESULT WAS 816 NG/DL. NO QUESTIONABLE RESULTS WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555006 ↗
• 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 13, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY AND ELECSYS TESTOSTERONE II ASSAY RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS 6000 CORE UNIT 150 (CN VERS.) AND COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TESTOSTERONE II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ESTRADIOL III ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE COBAS E 601 ANALYZER RESULTS WERE INCONSISTENT WITH THE PATIENTS' CLINICAL STATUSES. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008568 ↗

Other Roche Diagnostics GmbH products

• cobas e 411 Immunoassay Analyzer2 models · 1,218 reports
• cobas e 801 Immunoassay analyzer3 models · 713 reports · 1 recall
• CoaguChek XS PT strips2 models · 632 reports
• CoaguChek XS Patient Self Testing Care Kit2 models · 346 reports
• Elecsys FT3 III4 models · 283 reports
• Elecsys Estradiol III2 models · 162 reports
• Elecsys TSH4 models · 155 reports
• Sodium electrode3 models · 150 reports