Elecsys free PSA 09744908190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336217672), received between Jul 25, 2025 and Aug 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Output Problem; Output Problem

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. THE FREE PSA RESULTS WERE HIGHER THAN THE ELECSYS TOTAL PSA (TOTAL PSA) RESULTS. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. EXAMPLES OF QUESTIONABLE RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES. PATIENT 1 FREE PSA RESULT WAS 0.0176 NG/ML. THE TOTAL PSA RESULT WAS 0.0073 NG/ML. PATIENT 2 FREE PSA RESULT WAS 0.0166 NG/ML. THE TOTAL PSA RESULT WAS 0.006 NG/ML WITH A DATA FLAG. ON (B)(6) 2025 PATIENT 3 FREE PSA RESULT WAS 0.0203 NG/ML. THE TOTAL PSA RESULT WAS 0.0110 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893304 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL 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 22612925 ↗