Elecsys total PSA 08791686160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336165997), received between Jan 27, 2023 and Dec 4, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 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.

• MalfunctionDec 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TOTAL PSA (TOTAL PSA) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AS IT WAS NOT REFLECTIVE OF THE PATIENT'S CONDITION. THE INITIAL RESULT FROM THE ANALYZER WAS 0.06 NG/ML. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 4.2 NG/ML. THIS REPEAT RESULT WAS DEEMED CORRECT.  THE SECOND REPEAT RESULT FROM THEIR OTHER E 411 WAS 4.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261803 ↗
• MalfunctionAug 29, 2023Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 3 PATIENTS TESTED FOR ELECSYS TOTAL PSA (TOTAL PSA) THAT DID NOT CORRESPOND TO THEIR CLINICAL HISTORY ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023 PATIENT 1 RESULT WAS 1.3 NG/ML. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 229 NG/ML. ON (B)(6) 2023 PATIENT 2 RESULT WAS LESS THAN 0.01 NG/ML. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 4.69 NG/ML. ON (B)(6) 2023 PATIENT 3 RESULT WAS 0.02 NG/ML. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 32.2 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641224 ↗
• MalfunctionJan 27, 2023Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH TOTAL PSA ELECSYS RESULT FOR ONE PATIENT FROM THE COBAS E 411 RACK ANALYZER. THE INITIAL RESULT WAS 16.58 NG/ML AND THE REPEAT RESULT ON (B)(6) 2023 AFTER DEFROSTING THE SAMPLE WAS 0.531 NG/ML. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS QUESTIONED BY THE LABORATORY DIRECTOR, AS IT DID NOT MATCH THE HISTORY OF THE PATIENT. THE REAGENT LOT NUMBER WAS 59860000 WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254737 ↗