ONLINE TDM Acetaminophen Gen.2 08056684190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336120934), received between May 16, 2025 and Dec 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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 18, 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.

• MalfunctionDec 8, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE TDM ACETAMINOPHEN GEN. 2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 48.5 UG/ML. THE NURSE QUESTIONED THE RESULT, WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED TWICE ON ANOTHER MODULE, AND BOTH REPEAT RESULTS WERE <5 UG/ML WITH A FLAG. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744963 ↗
• MalfunctionMay 16, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ACETAMINOPHEN RESULTS FOR 11 PATIENT SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULTS RANGED FROM >200 TO 12 UG/ML. THE REPEAT RESULTS WERE ALL <5 UG/ML. A SPECIFIC EXAMPLE WAS PROVIDED ON AN INITIAL RESULT OF 50 UG/ML AND A REPEAT RESULT OF <5 UG/ML. SOME PATIENTS WERE TREATED WITH AN ANTI-ACETAMINOPHEN DRUG, BUT THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035908 ↗