VITROS 6801696Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750006601), received between Apr 3, 2025 and Apr 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 14, 2023Open, Classified

   Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

   Z-1664-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionApr 3, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS VANC RESULTS WERE OBTAINED FROM A TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM PV I LOT C2150 RESULTS OF 15.55, 15.42, 19.99 AND 20.49 UG/ML VS. THE BASELINE MEAN OF 7.73 UG/ML VITROS TDM PV III LOT E2152 RESULTS OF <5.0, <5.0, <5.0, <5.0 UG/ML AND 7.44 UG/ML VS. THE BASELINE MEAN OF 32.0 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761165 ↗