VITROS 6802454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750002801), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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 19, 2025False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, NON-REACTIVE (NEGATIVE) VITROS ANTI-HCV (AHCV) RESULT WAS OBTAINED FROM A NON-VITROS RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME (RIQAS) PROFICIENCY FLUID USING VITROS IMMUNODIAGNOSTIC PRODUCTS AHCV REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE REPEAT REACTIVE RESULTS FROM THE SAME SAMPLE ACROSS TWO ANALYZERS. RIQAS PROFICIENCY SAMPLE RESULT OF 0.66 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF 1.18 S/C (REACTIVE) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NON-REACTIVE VITROS AHCV RESULT WAS OBSERVED USING A NON-PATIENT FLUID AND WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848895 ↗