Elecsys Total PSA 09744860190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336217665), received between Jul 3, 2025 and Mar 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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 16, 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.

• MalfunctionMar 30, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PSA ELECSYS E2G ASSAY ON A COBAS E 801 ANALYTICAL UNIT, NOT MATCHING THE EXPECTED RESULTS. INITIAL RESULT: <0.014 NG/ML. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AS 0.014 NG/ML (NOT <0.014 NG/ML), AND ACCOMPANIED BY "ERROR 27". THE RESULT OF 0.014 NG/ML WAS HIGHER THAN THE LABORATORY'S RULE OF 0.006 NG/ML AND WAS SENT TO THE PHYSICIAN. IT WAS CONSIDERED INACCURATE AS THE PHYSICIAN AND THE PATIENT EXPECTED A RESULT LOWER THAN THE REPORTABLE RANGE OF <0.006 NG/ML. THE SAMPLE WAS THEN REPEATED ON A DIFFERENT INSTRUMENT AT THE CUSTOMER'S SITE WITH A LABORATORY-DEVELOPED TEST WHOSE VERSION HAD NOT BEEN UPDATED, AND THE REPEAT RESULT WAS <0.006 NG/ML (ACCOMPANIED BY A DATA FLAG). THE RESULT OF <0.014 NG/ML USING THE UPDATED LABORATORY'S RULE WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715641 ↗
• MalfunctionFeb 24, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH TOTAL PSA ELECSYS E2G RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 100 G/L. THE REPEAT RESULT USING A DILUTION WAS 5000 G/L WITH A DATA FLAG. ON (B)(6) 2026, THE SAMPLE WAS REPEATED USING PEG, AND THE RESULT WAS 100 G/L. THE PHYSICIAN BELIEVED THAT THIS WAS NOT RELIABLE, ESPECIALLY AS THE PATIENT DIDN'T HAVE ANY SYMPTOMS AND WAS BEING TESTED AS A ROUTINE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427941 ↗
• MalfunctionJul 25, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS TOTAL PROSTATE SPECIFIC ANTIGEN (TOTAL PSA) ASSAY AND ELECSYS FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. SAMPLE 1: TOTAL PSA: INITIAL RESULT: 0.0821 NG/ML. FREE PSA: INITIAL RESULT: 1.99 NG/ML. THIS FREE PSA RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE FREE PSA RESULT WAS GREATER THAN THE TOTAL PSA RESULT, PROMPTING THE REPEAT OF THE SAMPLE THE NEXT DAY. THE REPEAT RESULTS WERE IDENTICAL TO THE INITIAL RESULTS. ON (B)(6) 2025, A NEW BLOOD SAMPLE (SAMPLE 2) WAS TAKEN FROM THE PATIENT AND TESTED: TOTAL PSA RESULT: 0.0807 NG/ML. FREE PSA RESULT: 1.99 NG/ML. OTHER TOTAL PSA AND FREE PSA TESTS WERE PERFORMED AT A DIFFERENT SERVICE LABORATORY USING SIEMENS ATELLICA SOLUTION, RESULTING IN THE FOLLOWING: TOTAL PSA RESULT: 1.220 UG/L. FREE PSA RESULT: 0.023 UG/L. THESE RESULTS WERE DEEMED TO BE CORRECT. IT IS NOT KNOWN IF SAMPLE 2 WAS REPEATED ON SIEMENS TESTING OR IF ANOTHER NEW S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612651 ↗
• MalfunctionJul 3, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PROSTATE SPECIFIC ANTIGEN (TOTAL PSA) ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 0.6 NG/ML. ON (B)(6) 2025: REPEAT RESULT: 31.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393423 ↗