Elecsys Testosterone II 07027915190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630939817), received between Nov 12, 2018 and Sep 5, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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.

• MalfunctionSep 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO, ELECSYS ANTI-TG, ELECSYS ANTI-TSHR, AND ELECSYS TESTOSTERONE II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE ELECSYS TESTOSTERONE II ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TG ASSAY RESULTS, MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TSHR ASSAY RESULTS, AND MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TPO ASSAY RESULTS. REFER TO THE HIGHLIGHTED SECTION OF ATTACHMENT(B)(6) FOR PATIENT RESULTS. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT MATCHING THE CLINICAL STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146076 ↗
• MalfunctionMay 15, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TESTOSTERONE G2 ELECSYS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS 1029 NG/DL. THE SAMPLE WAS REPEATED BY BECKMAN METHODOLOGY AND THE RESULT WAS 752.75 NG/DL. ON (B)(6) 2023, THE REAGENT CASSETTE WAS EXCHANGED AND THE ASSAY RECALIBRATED. THE SAMPLE WAS REPEATED WITH A RESULT OF 1024 NG/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE CLINICIAN QUESTIONED THE RESULTS. IT WAS NOT KNOWN WHICH RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932111 ↗
• MalfunctionAug 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS >15 NG/ML. THE CUSTOMER DECIDED TO REPEAT TESTING DUE TO THE RESULT NOT MATCHING THE PATIENT¿S CLINICAL PICTURE. THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY ON A ROCHE ELECSYS WITH A RESULT OF 7.5 NG/ML. IT IS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308181 ↗
• MalfunctionNov 12, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO AN ADVIA CENTAURO. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS FT3 III, ELECSYS PROLACTIN ASSAY, ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS TESTOSTERONE II ASSAY, AND ELECSYS ESTRADIOL III ASSAY. THE CUSTOMER SUSPECT THERE IS AN INTERFERENCE AFFECTING THE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE TESTOSTERONE ASSAY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6). THE DISCREPANT RESULTS ARE HIGHLIGHTED. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059173 ↗