cobas® HCV 09040765190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00875197006391), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE POSITIVE COBAS® HCV (192T) RESULTS FOR 2 PATIENT PLASMA SAMPLES TESTED ON THE COBAS 8800 ANALYZER. PATIENT 1 INITIAL RESULT WAS 2.27E+001 IU/ML (HCV DETECTED). ON (B)(6) 2024, THE REPEAT RESULT FROM A NEW SAMPLE COLLECTED (B)(6) 202 WAS TARGET NOT DETECTED. ON (B)(6) 2024, A NEW SAMPLE WAS COLLECTED AND ANTIBODY TESTING FOR HCV WAS NEGATIVE. PATIENT 2 INITIAL RESULT WAS 3.30E+001 IU/ML (HCV DETECTED). ON (B)(6) 2024, A NEW SAMPLE WAS COLLECTED AND ANTIBODY TESTING FOR HCV WAS NEGATIVE. ON (B)(6) 2024, A NEW SAMPLE WAS COLLECTED AND ANTIBODY TESTING FOR HCV WAS NEGATIVE. ON (B)(6) 2024, THE REPEAT RESULT FROM A NEW SAMPLE COLLECTED (B)(6) 2024 WAS TARGET NOT DETECTED. THE RESULTS WERE REPORTED AS INDETERMINATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580028 ↗