VITROS 6801732Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750006816), received between Jan 30, 2024 and Jan 30, 2024 — 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.

• MalfunctionJan 30, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-1578 ON A VITROS 4600 CHEMISTRY SYSTEM. NON-VITROS BIORAD IMMUNOLOGY LEVEL 1 QC LOT 85701 RESULTS OF <40.00, <40.00, <40.00, AND <40.00 UG/ML VERSUS THE EXPECTED RESULT OF 115.413 UG/ML NON-VITROS BIORAD IMMUNOLOGY LEVEL 3 QC LOT 85703 RESULTS OF 184.70, 178.39, 176.11, AND 178.38 UG/ML VERSUS THE EXPECTED RESULT OF 301.726 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 THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM A CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. 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 18608180 ↗