VITROS 1728872Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750000029), received between Jul 13, 2023 and Jul 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “High 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED FREE T4 (FT4) RESULTS WERE OBTAINED FROM A PATIENT SAMPLE AND FROM A VITROS FREE THYROID QUALITY CONTROL FLUID WHEN RUNNING VITROS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 1.01 NG/DL VERSUS THE EXPECTED RESULT OF 0.71 NG/DL VITROS FREE THYROID CONTROL LOT 0761 RESULT OF 1.18 NG/DL VERSUS THE EXPECTED RESULT OF 0.75 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS FT4 RESULTS WERE OBTAINED FROM QC FLUID AND FROM REPEAT PATIENT TESTING AND WERE NOT REPORTED FROM LABORATORY AS THE SAMPLE WAS REPEATED FOR TROUBLESHOOTING PURPOSES ONLY. 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 602528.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316922 ↗