VITROS 6844508Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10758750032105), received between Mar 23, 2023 and Jan 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2178-2019 · Root cause: Software design · FDA record ↗

2. Jul 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2185-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS MAS LEVEL 1 QUALITY CONTROL FLUID, LOT: OCR2608, USING VITROS NA+ SLIDE LOT: 4261-1141-5763 ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 2 NA+ RESULTS OF 197.6 AND 200.7 MMOL/L VS. THE EXPECTED RESULT OF 121.1 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286708 ↗
• MalfunctionOct 18, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE NON-VITROS BIORAD LEVEL 2 QUALITY CONTROL FLUID, LOT 92952, USING VITROS NA+ SLIDE LOT 4254-1134-2426 ON A VITROS XT 3400 CHEMISTRY SYSTEM. BIORAD LEVEL 2 NA+ RESULT OF 106.9 MMOL/L VS. THE EXPECTED RESULT OF 157.4 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WERE NO ALLEGATIONS OF 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 20481863 ↗
• MalfunctionMar 7, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 56700, USING VITROS K+ SLIDE LOT 4102-1112-7951 AND SLIDE LOT 4102-1129-8320 ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM. VITROS K+ SLIDE LOT 4102-1112-7951 BIORAD LOT 56700 LEVEL 3 RESULTS OF 4.17 AND 4.08 MMOL/L VS. THE VITROS PEER MEAN OF 7.79 MMOL/L VITROS K+ SLIDE LOT 4102-1129-8320 BIORAD LOT 56700 LEVEL 3 RESULTS OF 4.27 AND 4.37 MMOL/L VS. THE VITROS PEER MEAN OF 7.79 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED AT THE SAME MAGNITUDE IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855480 ↗
• MalfunctionFeb 2, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED WHEN PROCESSING LEVEL 2 BIORAD LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LOT 92960 AFTER A CALIBRATION EVENT DUE TO THE CHANGE IN LOTS OF REFERENCE FLUID. VITROS NA+ RESULTS 143.8 AND 144.5 VERSUS THE BASELINE MEAN OF 155.3 UMOL/L IN ADDITION TO THE LOWER THAN EXPECTED VITROS NA+ RESULTS NOTED ABOVE, WHEN REVIEWING THE HISTORICAL QUALITY CONTROL RESULTS IT WAS DETERMINED THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS NA+ RESULT WHEN PROCESSING LEVEL 1 BIORAD LIQUICHEK UNASSAYED CHEMISTRY CONTROL LOT 92960. VITROS NA+ RESULT OF 138.1 MMOL/L VERSUS THE BASELINE MEAN OF 125.3 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 AND LOWER THAN EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS. THE CUSTOMER ALSO OBTAINED LOWER THAN EXPECTED VITROS NA+ RESULTS WHEN PROCESSING PATIENT SAMPLES AS PART OF THEIR CALIBRATION VERIFICATION PROCEDURE. THE TESTING OF PATIENT SAMPLES WAS PERFORMED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636011 ↗
• MalfunctionDec 1, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED POTASSIUM (K+) RESULTS WERE OBTAINED WHEN PROCESSING BIORAD MULTIQUAL QC LOT 56690 AFTER THE CALIBRATION OF TWO VITROS K+ SLIDE LOTS USING THE SAME SET OF CALIBRATOR FLUIDS. VITROS CHEMISTRY PRODUCTS K+ SLIDES, LOT 4102-1111-5623 CALIBRATION CURVE 4365 VITROS K+ RESULT >14 MMOL/L VERSUS BIORAD PEER MEAN 2.64 MMOL/L VITROS CHEMISTRY PRODUCTS K+ SLIDES, LOT 4102-1089-3607 CALIBRATION CURVE 4362 VITROS K+ RESULTS >14, >14, >14, >14, AND >14 MMOL/L VERSUS BIORAD PEER MEAN 2.64 MMOL/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 K+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249388 ↗
• MalfunctionJun 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF BIORAD UNASSAYED CONTROL LOT 92940 USING VITROS NA+ SLIDE LOT 4212-1097-5923 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 92940 LEVEL 1 RESULTS OF 135.7 AND 135.5 MMOL/L VS. THE EXPECTED RESULT OF 128 MMOL/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 RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THREE UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY ALLEGATIONS 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 17216858 ↗
• MalfunctionMar 23, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED FROM A SINGLE VITROS CALIBRATOR KIT 32 LEVEL 1 FLUID, LOT: 3222 USING VITROS K+ SLIDE LOT: 4102-0857-3923 ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM, WHICH BREACHED POTENTIAL HEALTH AND SAFETY CRITERIA. VITROS CALIBRATOR KIT 32, LOT: 3222 LEVEL 1 VITROS K+ RESULTS OF 6.15 AND 6.12 MMOL/L VS. THE VITROS ASSIGNED VALUE OF 1.00 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600829 ↗