VITROS 1149764Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750008483), received between Mar 15, 2023 and Mar 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED RESULT ABOVE THE VITROS AMON MEASURING RANGE OF 8.7 - 500 UMOL/L OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS AMMONIA (AMON) SLIDE LOT 1020-0268-5975 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF >500 UMOL/L VS. THE EXPECTED RESULT OF 102 UMOL/L. 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 AMON RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613873.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664765 ↗
• MalfunctionOct 22, 2024High 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 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT 54390, USING VITROS AMMONIA (AMON) SLIDE LOTS 1019-0266-5803 AND SLIDE LOT 1020-0265-0764 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS AMON REAGENT SLIDE LOT 1020-0265-0764: BIORAD LEVEL 2 AMON RESULTS OF 61.71, 63.51, 112.45, 68.28, 70.84, 68.46, AND 62.67 ?MOL/L VS. THE EXPECTED RESULT OF 92.88 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 187.76 ?MOL/L VS. THE EXPECTED RESULT OF 239.90 ?MOL/L VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 122.83, 113.59, 72.81, AND 59.75 ?MOL/L VS. THE EXPECTED RESULT OF 92.40 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 184.23 ?MOL/L VS. THE EXPECTED RESULT OF 242.10 ?MOL/L LIQUID PERFORMANCE VERIFIER II AMON RESULTS OF 129.17, 142.36, 143.74, 145.21, 145.97, 148.40, 149.81, 150.95, 152.00, 152.40, 153.53 AND 154.35 ?MOL/L VS. THE EXPECTED RESULT OF 194.70 ?MOL/L AFTER SERVICE INTERVENTIONS USING VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 115.40, 115.04, AND 112.20 ?MOL/L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509679 ↗
• MalfunctionMar 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0259-0222 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD CONTROL LOT 54360 LEVEL 2 VITROS AMON RESULTS OF 126.9, 123.0 AND 120.8 UMOL/L VERSUS AN EXPECTED RESULT OF 93.1 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED OR QUESTIONED. ORTHO WAS NOT MADE AWARE OF ANY 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 16547962 ↗