Elecsys free PSA 08828601160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336166673), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA IMMUNOASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2022, THE ELECSYS PSA RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLE ON THE SAME E 601 MODULE. ON (B)(6) 2022, A NEW SAMPLE WAS COLLECTED AND TESTED ON THE E 601 MODULE. ON (B)(6) 2022, THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY AND THE SAMPLE WAS TESTED WITH CHEMILUMINESCENCE METHODOLOGY. ON (B)(6) 2022, THE PATIENT'S INITIAL RESULTS ON THE E 601 MODULE WERE TOTAL PSA 0.80 NG/ML AND FREE PSA 1.33 NG/ML. THE PATIENT'S REPEAT RESULTS ON THE E 601 MODULE WERE TOTAL PSA 0.81 NG/ML AND FREE PSA 1.39 NG/ML. ON (B)(6) 2022, THE PATIENT'S NEW SAMPLE WAS TESTED ON THE E 601 MODULE AND THE RESULTS WERE TOTAL PSA 0.084 NG/ML AND FREE PSA 1.30 NG/ML. ON (B)(6) 2022, THE PATIENT'S RESULTS WITH THE CHEMILUMINESCENCE METHODOLOGY WERE TOTAL PSA 0.93 NG/ML AND FREE PSA 0.02 NG/ML. THE ELECSYS TOTAL PSA REAGENT LOT NUMBER WAS 556098 WITH AN EXPIRATION DATE OF 30-NOV-2022. THE ELECSYS FREE PSA REAGENT LOT NUMBER WAS 546160 WITH AN EXPIRATION DATE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006114 ↗