VITROS 1037274Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750008339), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS ACETAMINOPHEN (ACET) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE INITIAL RESULT FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE 1 VITROS ACET REPEAT RESULT OF < 2.0 MG/DL VS. THE INITIAL RESULT OF > 20.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS ACET RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE HAS BEEN NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 612879.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821474 ↗