VITROS 8568040Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10758750005031), received between May 4, 2023 and Sep 22, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Oct 13, 2022Open, Classified

   Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

   Z-0220-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858628 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858571 ↗
• MalfunctionFeb 19, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUID USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES ON TWO VITROS XT 7600 INTEGRATED SYSTEM. J76001840: TDM PVI LOT C2150 RESULTS OF 6.4 AND 6.6 UG/ML VS THE EXPECTED RESULT OF 8.65 UG/ML J76001731: TDM PVI LOT C2150 RESULTS OF 6.2, 6.1, 6.5, 6.2, 6.3, AND 6.1 UG/ML VS THE EXPECTED RESULT OF 8.65 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 PHYT RESULTS WERE OBTAINED FROM A VITROS TDM PV FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED DURING THE TIMEFRAME THE TDM PV RESULTS WERE OUTSIDE EXPECTATION. THERE HAS BEEN NO REPORTED 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 21412005 ↗
• MalfunctionNov 26, 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 VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM VITROS PHYT LOT 2628-0189-4974 USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROLS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 92981 VITROS PHYT RESULTS OF 8.05, 7.01, 6.03, 8.99, 13.86, 14.01, 14.58, 15.31, 14.05, 14.26, 14.65, 14.24, 14.91, 14.55, AND 14.88 UG/ML VERSUS THE BASELINE MEAN RESULT OF 11.49 UG/ML BIORAD LEVEL 2 LOT 92982 VITROS PHYT RESULTS OF 34.35, 34.67, 19.30, 21.11, AND 21.51 UG/ML VERSUS THE BASELINE MEAN RESULT OF 28.13 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 AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NOT ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER FOUR OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782095 ↗
• MalfunctionNov 26, 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 VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM VITROS PHYT LOT 2628-0189-4974 USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROLS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 92981 VITROS PHYT RESULTS OF 8.05, 7.01, 6.03, 8.99, 13.86, 14.01, 14.58, 15.31, 14.05, 14.26, 14.65, 14.24, 14.91, 14.55, AND 14.88 UG/ML VERSUS THE BASELINE MEAN RESULT OF 11.49 UG/ML BIORAD LEVEL 2 LOT 92982 VITROS PHYT RESULTS OF 34.35, 34.67, 19.30, 21.11, AND 21.51 UG/ML VERSUS THE BASELINE MEAN RESULT OF 28.13 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 AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NOT ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780463 ↗
• MalfunctionNov 26, 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 VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM VITROS PHYT LOT 2628-0189-4974 USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROLS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 92981 VITROS PHYT RESULTS OF 8.05, 7.01, 6.03, 8.99, 13.86, 14.01, 14.58, 15.31, 14.05, 14.26, 14.65, 14.24, 14.91, 14.55, AND 14.88 UG/ML VERSUS THE BASELINE MEAN RESULT OF 11.49 UG/ML BIORAD LEVEL 2 LOT 92982 VITROS PHYT RESULTS OF 34.35, 34.67, 19.30, 21.11, AND 21.51 UG/ML VERSUS THE BASELINE MEAN RESULT OF 28.13 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 AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NOT ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780356 ↗
• MalfunctionNov 26, 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 VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM VITROS PHYT LOT 2628-0189-4974 USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROLS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 92981 VITROS PHYT RESULTS OF 8.05, 7.01, 6.03, 8.99, 13.86, 14.01, 14.58, 15.31, 14.05, 14.26, 14.65, 14.24, 14.91, 14.55, AND 14.88 UG/ML VERSUS THE BASELINE MEAN RESULT OF 11.49 UG/ML BIORAD LEVEL 2 LOT 92982 VITROS PHYT RESULTS OF 34.35, 34.67, 19.30, 21.11, AND 21.51 UG/ML VERSUS THE BASELINE MEAN RESULT OF 28.13 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 AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NOT ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779240 ↗
• MalfunctionNov 26, 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 VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM VITROS PHYT LOT 2628-0189-4974 USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROLS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 92981 VITROS PHYT RESULTS OF 8.05, 7.01, 6.03, 8.99, 13.86, 14.01, 14.58, 15.31, 14.05, 14.26, 14.65, 14.24, 14.91, 14.55, AND 14.88 UG/ML VERSUS THE BASELINE MEAN RESULT OF 11.49 UG/ML BIORAD LEVEL 2 LOT 92982 VITROS PHYT RESULTS OF 34.35, 34.67, 19.30, 21.11, AND 21.51 UG/ML VERSUS THE BASELINE MEAN RESULT OF 28.13 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 AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NOT ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER TWO OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779139 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193724 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192997 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192806 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192336 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192263 ↗
• MalfunctionSep 11, 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 VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192262 ↗
• MalfunctionJun 26, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULT WAS OBTAINED FROM A SINGLE COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOT 2511-0107-8229 ON A VITROS XT 7600 INTEGRATED SYSTEM. PROFICIENCY SAMPLE CHM-05 RESULT OF 32.0 VS. THE CAP PEER TARGET 25.97 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 HIGHER THAN EXPECTED VITROS PHBR RESULT WAS OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. NO VITROS PHBR PATIENT RESULTS HAVE BEEN QUESTIONED BY THE CUSTOMER AND 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 19617854 ↗
• MalfunctionMar 19, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED FROM A VITROS TDM III PV QC FLUID WHEN USING VITROS CHEMISTRY PRODUCTS PHYT SLIDE LOT 2627- 0187-7864 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS QC RESULTS WERE COMPARED TO THE CENTER OF THE VITROS TDM PV RANGE OF MEANS. VITROS TDM III X1172 = 32.3, 32.4, 32.5 VERSUS EXPECTED 26.2 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-PATIENT SAMPLES. THERE WAS NO REPORTED 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 18928685 ↗
• MalfunctionNov 14, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS PHYT RESULT WAS OBTAINED FROM A SINGLE NON-VITROS BIORAD LOT 45960 LEVEL 3 QUALITY CONTROL FLUID USING VITROS PHYT SLIDE LOT 2626-0186-4395 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LOT 45960 LEVEL 3 VITROS PHYT RESULT OF 13.7 UG/ML VERSUS THE EXPECTED RESULT OF 17.12 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 RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131865 ↗
• MalfunctionMay 4, 2023High 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 HIGHER AND LOWER THAN EXPECTED PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QC FLUID AND FROM ONE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT 2504-0091-0846 ON A VITROS XT7600 INTEGRATED SYSTEM. TDM PVI LOT K9187 VITROS PHBR RESULTS OF 10.11, 10.26 AND 10.32 UG/ML VERSUS THE EXPECTED RESULT OF 13.56 UG/ML BIORAD LEVEL 1 LOT 85311 VITROS PHBR RESULTS OF 7.07, 16.43 AND 15.68 UG/ ML VERSUS THE EXPECTED RESULT OF 10.3 UG/ML BIORAD LEVEL 3 LOT 85313 VITROS PHBR RESULT OF 98.99 UG/ ML VERSUS THE EXPECTED RESULT OF 73.3 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 HIGHER AND LOWER THAN EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868641 ↗