Elecsys total PSA 08791716160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336166000), received between Dec 28, 2022 and Mar 14, 2024 — classified as 2 malfunctions.

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

• MalfunctionMar 14, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PSA ELECSYS RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. PATIENT 1 INITIAL RESULT WAS <0.010 NG/ML AND REPEAT THE RESULT WAS APPROXIMATELY 9 NG/ML. PATIENT 2 INITIAL RESULT WAS <0.010 NG/ML AND THE REPEAT RESULT WAS APPROXIMATELY 4 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904165 ↗
• MalfunctionDec 28, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL TOTAL PSA RESULT WAS 0.032 NG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 3.01 NG/ML AND 2.97 NG/ML. THE RESULT OF 3.01 NG/ML WAS DEEMED CORRECT. THE REAGENT LOT IS 64096301 AND THE EXPIRATION DATE IS 31-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061672 ↗