Elecsys total PSA 07027966190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939824), received between Aug 17, 2018 and May 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Signal Artifact/Noise; Incorrect Measurement; Signal Artifact/Noise; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS FREE PSA ASSAY. PATIENT 1'S FREE PSA RESULT ON (B)(6) 2025, WAS 3.33 NG/ML, AND THE TOTAL PSA RESULT WAS 2.46 NG/ML. A NEW SAMPLE WAS REQUESTED ON (B)(6) 2025, AND THE FREE PSA RESULT WAS 2.48 NG/ML, AND THE TOTAL PSA RESULT WAS 1.78 NG/ML. PATIENT 2'S FREE PSA RESULT ON (B)(6) 2025, WAS 0.798 NG/ML, AND THE TOTAL PSA RESULT WAS 0.220 NG/ML. PATIENT 3'S FREE PSA RESULT ON (B)(6) 2025, WAS 0.332 NG/ML, AND THE TOTAL PSA RESULT WAS 0.903 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106088 ↗
• MalfunctionJul 14, 2021High Test Results; Insufficient Device Problem Information; High Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FREE PSA IMMUNOASSAY AND ELECSYS TOTAL PSA IMMUNOASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMED QC WAS ACCEPTABLE. THE PATIENT HAD A SAMPLE COLLECTED ON (B)(6) 2021 FOR FREE PSA AND TOTAL PSA TESTING. ON EACH DATE OF TESTING, THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER QUESTIONED THE REPORTED FREE PSA AND TOTAL PSA RESULTS. THE PATIENT'S SAMPLES WERE NOT REPEATED DUE TO THE SAMPLES BEING DISCARDED. ON (B)(6) 2021, THE PATIENT'S RESULTS WERE FREE PSA 4.240 NG/ML AND TOTAL PSA 1.34 NG/ML. ON (B)(6) 2021, THE PATIENT'S RESULTS WERE FREE PSA 4.810 NG/ML AND TOTAL PSA 1.630 NG/ML. THE CUSTOMER WAS UNSURE WHICH E 801 MODULE WAS USED FOR TESTING. THE E 801 MODULE SERIAL NUMBERS ARE (B)(4). THIS MEDWATCH IS FOR TOTAL PSA. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FREE PSA ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167891 ↗
• MalfunctionAug 17, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS FREE PSA IMMUNOASSAY AND ELECSYS TOTAL PSA IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E801 MODULE. THE CUSTOMER SUSPECTS THAT THERE IS AN INTERFERENCE PRESENT IN THE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE TOTAL PSA DATA. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR DATA ON THE FREE PSA. THE INITIAL FREE PSA RESULT WAS 3.87 NG/ML WITH REPEAT RESULTS OF 3.91 NG/ML AND 3.65 NG/ML. THE INITIAL TOTAL PSA RESULT WAS 3.00 NG/ML WITH REPEAT RESULTS OF 3.05 NG/ML AND 2.99 NG/ML. NO ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792763 ↗