VITROS 8892382Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10758750005185), received between Nov 2, 2023 and May 22, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025High 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 FROM MULTIPLE VITROS IMMUNORATE SLIDE ASSAYS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS THERMOFISHER MAS OMNICORE CONTROLS (MAS) LOT OCR2608 AND A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III LOT E2152 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS CARBAMAZEPINE (CRBM) SLIDE LOT 3920-0129-0168 MAS LOT OCR2608 L2 RESULTS OF 13.1 AND 12.6 UG/ML VS. THE EXPECTED RESULT OF 9.48 UG/ML. VITROS CRBM SLIDE LOT 3919-0128-9593 VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III LOT E2152 RESULTS OF 9.0, 8.9, 6.3, 7.4, AND >20 UG/ML VS. THE EXPECTED RESULT OF 14.38 UG/ML. POST-SERVICE VITROS TDM PV III LOT E2152 RESULTS OF >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20, >20 AND >20 UG/ML VS. THE EXPECTED RESULT OF 14.38 UG/ML. VITROS PHENOBARBITAL (PHBR) SLIDE LOT 2516-0114-0757 MAS LOT OCR2608 L1 RESULTS OF 15.7, 17.1, 14.5, 15.7, 13.3, 15.0, 13.7, 13.5, 16.4 AND 15.8 UG/ML VS. THE EXPECTED RESULT OF 10.0 UG/ML. MAS LOT OCR2608 L2 RESULTS OF 26.0, 28.6, 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070415 ↗
• MalfunctionFeb 5, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) MATERIAL USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3916-0125-4879 ON A VITROS XT 7600 INTEGRATED SYSTEM. EVENTS OBSERVED ON 19 DECEMBER 2024 AND 20 DECEMBER 2024: VITROS TDM PVI (LOT C2150) CRBM RESULT OF 9.20 AND 8.76 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 4.83 UG/ML VITROS TDM PVIII (LOT E2152) CRBM RESULT OF 20.00 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 14.89 UG/ML EVENTS OBSERVED ON 28 JANUARY 2025: VITROS TDM PVI (LOT C2150) CRBM RESULT OF 9.74 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 4.83 UG/ML VITROS TDM PVIII (LOT E2152) CRBM RESULT OF 19.55 UG/ML VERSUS THE CUSTOMER'S BASELINE MEAN VALUE OF 14.89 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 CRBM RESULTS WERE OBTAINED WHEN PROCESSING A NON-PATIENT QUALITY CONTROL FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317890 ↗
• MalfunctionMar 7, 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 CRBM RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 56720 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 56720 LEVEL 1 CRBM RESULT OF 7.42 UG/ML VS. THE EXPECTED RESULT OF 3.75 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 CRBM RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WOULD BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO REPORTED 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 18855595 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL LOT 85310 TESTED ON A XT7600 INTEGRATED SYSTEM. BIORAD LOT 85310 LEVEL 2 CRBM RESULTS OF 9.69, 9.24 AND 9.79 UG/ML VS. THE EXPECTED RESULT OF 6.22 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 CRBM RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 603682.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059275 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL LOT 85310 TESTED ON A XT7600 INTEGRATED SYSTEM. BIORAD LOT 85310 LEVEL 2 CRBM RESULTS OF 9.69, 9.24 AND 9.79 UG/ML VS. THE EXPECTED RESULT OF 6.22 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 CRBM RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. 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 18059250 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CARBAMAZEPINE (CRBM) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL LOT 85310 TESTED ON A XT7600 INTEGRATED SYSTEM. BIORAD LOT 85310 LEVEL 2 CRBM RESULTS OF 9.69, 9.24 AND 9.79 UG/ML VS. THE EXPECTED RESULT OF 6.22 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 CRBM RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. 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 18058631 ↗