VITROS 1204668Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750008537), received between Nov 20, 2024 and Nov 20, 2024 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Feb 18, 2021Terminated

   Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).

   Z-1295-2021 · Root cause: Process design · Recall details · 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.

• MalfunctionNov 20, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS BILIRUBIN UNCONJUGATED (BU) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER II LOT A2114 FLUID TESTED USING VITROS BU SLIDE LOT 0238-0469-9224 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE LOWER-THAN-EXPECTED RESULT WAS OBTAINED AFTER CALIBRATING THE VITROS BU ASSAY. VITROS PV II LOT A2114 BU RESULTS OF <-0.3, <-0.3, <-0.3, AND <-0.3 MG/DL VERSUS THE RANGE OF MEAN MIDPOINT RESULT OF 8.90 MG/DL 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-THAN-EXPECTED VITROS BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID, AND PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737620 ↗