VITROS 8298671Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products PHYT Slides · Class 2
Quick summary
This Ortho-Clinical Diagnostics VITROS PHYT slide is used on VITROS analyzers to measure phenytoin (PHYT), an anti-seizure drug, in patient samples. The 53 reports mostly describe test results coming out lower or higher than expected, and in some cases results that could not be reproduced on repeat testing. All53 describe malfunctions, with no deaths and no injuries. One recall, started in June 2017 and since closed, concerned the possibility of biased results when the slides were run with citrate plasma samples.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10758750004690), received between Apr 25, 2023 and Sep 22, 2026 — classified as 67 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (48 reports).
1 FDA recall record 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.
Reports received per month
Recalls naming this device
- Jun 12, 2017Terminated
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Z-0273-2018 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Low Test Results48
- High Test Results44
- Non Reproducible Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions67
Recent adverse event reports
The 25 most recent of 67 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 50858751 ↗MalfunctionSep 22, 2026High Test Results; Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858728 ↗MalfunctionSep 22, 2026High Test Results; Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858718 ↗MalfunctionSep 22, 2026High Test Results; Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858701 ↗MalfunctionSep 22, 2026High Test Results; Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858648 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715291 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715285 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715274 ↗MalfunctionSep 10, 2026High Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report higher than expected VITROS Phenytoin (PHYT) results were obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid, and lower than expected VITROS PHYT results were obtained from a non-VITROS MAS fluid using VITROS PHYT slide lot: 2631-0202-6006 on a VITROS 4600 Chemistry System. MAS Level 2 lot: OCR27042 results of 12.66, 12.36, 11.68, 12.43, 11.94, 12.64, 10.24 ug/mL versus the expected result of 16.3 ug/mL (midpoint of Range of Means) TDM PVIII lot: U3323 results of 35.3 and 35.6 ug/mL versus the expected result of 28.4 ug/mL (midpoint of Range of Means) 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 PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number eight of nine MDRs for this event. Nine 3500a forms are being submitted for this event as nine devices were involved. This report corresponds to Ortho
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715269 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715231 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715218 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715213 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715206 ↗MalfunctionSep 10, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715192 ↗MalfunctionAug 7, 2026Low Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS PHYT results obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid using VITROS Chemistry Products PHYT slide lot 2631-0202-6006 on a VITROS XT7600 Integrated System. VITROS TDM PV III lot U3323 VITROS PHYT results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/mL versus the expected result of 29.2 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 lower than expected VITROS PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number five of five 3500a forms being submitted for this event as five devices were involved. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615382.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181830 ↗MalfunctionAug 7, 2026Low Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS PHYT results obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid using VITROS Chemistry Products PHYT slide lot 2631-0202-6006 on a VITROS XT7600 Integrated System. VITROS TDM PV III lot U3323 VITROS PHYT results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/mL versus the expected result of 29.2 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 lower than expected VITROS PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number three of five 3500a forms being submitted for this event as five devices were involved. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615382.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181822 ↗MalfunctionAug 7, 2026Low Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS PHYT results obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid using VITROS Chemistry Products PHYT slide lot 2631-0202-6006 on a VITROS XT7600 Integrated System. VITROS TDM PV III lot U3323 VITROS PHYT results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/mL versus the expected result of 29.2 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 lower than expected VITROS PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number two of five 3500a forms being submitted for this event as five 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 50181796 ↗MalfunctionAug 7, 2026Low Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS PHYT results obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid using VITROS Chemistry Products PHYT slide lot 2631-0202-6006 on a VITROS XT7600 Integrated System. VITROS TDM PV III lot U3323 VITROS PHYT results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/mL versus the expected result of 29.2 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 lower than expected VITROS PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number four of five 3500a forms being submitted for this event as five 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 50181763 ↗MalfunctionAug 7, 2026Low Test Results
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS PHYT results obtained from a VITROS Therapeutic Drug Monitoring Performance Verifier (TDM PV) fluid using VITROS Chemistry Products PHYT slide lot 2631-0202-6006 on a VITROS XT7600 Integrated System. VITROS TDM PV III lot U3323 VITROS PHYT results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/mL versus the expected result of 29.2 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 lower than expected VITROS PHYT results were obtained from a non-patient quality control fluid. There were no allegations of patient harm as a result of this event. This report is number one of five 3500a forms being submitted for this event as five 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 50181639 ↗MalfunctionSep 15, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED, NON-REPRODUCIBLE PHENYTOIN (PHYT) RESULT FROM A SINGLE PATIENT SAMPLE USING VITROS PHYT SLIDE LOT 2627-0194-4131 PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS PHYT RESULT OF 56.7 UMOL/L VS. THE EXPECTED VITROS PHYT RESULT OF 85.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS PHYT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY 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 23057000 ↗MalfunctionJan 29, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED PHENYTOIN (PHYT) RESULT FROM A SINGLE PATIENT SAMPLE USING VITROS PHYT SLIDE LOT 2627-0190-6032 PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS PHYT RESULT OF 76.13 UMOL/L VS. THE EXPECTED VITROS PHYT RESULT OF 143.17 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED PHYT RESULT WAS REPORTED OUTSIDE OF THE LABORATORY; HOWEVER, NO TREATMENT WAS GIVEN, CHANGED, OR WITHHELD BASED ON THE REPORTED RESULT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN 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 21264581 ↗MalfunctionApr 22, 2024High Test Results; High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHEN PROCESSING VITROS TDM PERFORMANCE VERIFIERS AND NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON A VITROS XT7600 SYSTEM. VITROS PHYT SLIDE LOT 2627-0187-7862:(B)(6) 2024: VITROS TDM PV3 RESULT 32.6 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. VITROS PHYT SLIDE LOT 2627-0187-0219: (B)(6) 2024 VITROS PHYT RESULTS 18.98 AND 18.86 UG/ML VERSUS THE BASELINE MEAN OF 12.23 UG/ML. (B)(6) 2024 VITROS TDM PV3 RESULT OF 31.8 UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML.(B)(6) 2024: VITROS TDM PV3 RESULT 31.4 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. (B)(6) 2024: VITROS TDM PV3 RESULTS >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, 31.9, 34.8, 34.3, 33.5, AND 34.3 UG/ML UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. (B)(6) 2024: VITROS BIORAD MULTIQUAL UNASSAYED QC LOT 92963 VITROS PHYT RESULTS 32.0, 31.4, 31.6, 32.0, 31.7, 31.1, 32.0, 32.1, 30.8, 31.7, 32.5, 30.6, 31.7, 32.1, 31.1, 31.2, AND 31.6 UG/ML VERSUS THE CUSTOMER BASELINE MEAN 25.0 UG/ML. BIA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159945 ↗MalfunctionApr 22, 2024High Test Results; High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHEN PROCESSING VITROS TDM PERFORMANCE VERIFIERS AND NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON A VITROS XT7600 SYSTEM. VITROS PHYT SLIDE LOT 2627-0187-7862: (B)(6) 2024: VITROS TDM PV3 RESULT 32.6 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. VITROS PHYT SLIDE LOT 2627-0187-0219: (B)(6) 2024 VITROS PHYT RESULTS 18.98 AND 18.86 UG/ML VERSUS THE BASELINE MEAN OF 12.23 UG/ML. (B)(6) 2024 VITROS TDM PV3 RESULT OF 31.8 UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. (B)(6) 2024: VITROS TDM PV3 RESULT 31.4 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. (B)(6) 2024: VITROS TDM PV3 RESULTS >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, 31.9, 34.8, 34.3, 33.5, AND 34.3 UG/ML UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. (B)(6) 2024: VITROS BIORAD MULTIQUAL UNASSAYED QC LOT 92963 VITROS PHYT RESULTS 32.0, 31.4, 31.6, 32.0, 31.7, 31.1, 32.0, 32.1, 30.8, 31.7, 32.5, 30.6, 31.7, 32.1, 31.1, 31.2, AND 31.6 UG/ML VERSUS THE CUSTOMER BASELINE MEAN 25.0 UG/ML. BI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159840 ↗MalfunctionApr 22, 2024High Test Results; High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHEN PROCESSING VITROS TDM PERFORMANCE VERIFIERS AND NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON A VITROS XT7600 SYSTEM. VITROS PHYT SLIDE LOT 2627-0187-7862: (B)(6) 2024: VITROS TDM PV3 RESULT 32.6 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. VITROS PHYT SLIDE LOT 2627-0187-0219: (B)(6) 2024 VITROS PHYT RESULTS 18.98 AND 18.86 UG/ML VERSUS THE BASELINE MEAN OF 12.23 UG/ML. (B)(6) 2024 VITROS TDM PV3 RESULT OF 31.8 UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. (B)(6) 2024: VITROS TDM PV3 RESULT 31.4 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. (B)(6) 2024: VITROS TDM PV3 RESULTS >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, 31.9, 34.8, 34.3, 33.5, AND 34.3 UG/ML UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. (B)(6) 2024: VITROS BIORAD MULTIQUAL UNASSAYED QC LOT 92963 VITROS PHYT RESULTS 32.0, 31.4, 31.6, 32.0, 31.7, 31.1, 32.0, 32.1, 30.8, 31.7, 32.5, 30.6, 31.7, 32.1, 31.1, 31.2, AND 31.6 UG/ML VERSUS THE CUSTOMER BASELINE MEAN 25.0 UG/ML. BI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159815 ↗MalfunctionApr 22, 2024High Test Results; High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS WERE OBTAINED WHEN PROCESSING VITROS TDM PERFORMANCE VERIFIERS AND NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON A VITROS XT7600 SYSTEM. VITROS PHYT SLIDE LOT 2627-0187-7862: 4 MARCH 2024: VITROS TDM PV3 RESULT 32.6 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. VITROS PHYT SLIDE LOT 2627-0187-0219: 23 MARCH 2024 VITROS PHYT RESULTS 18.98 AND 18.86 UG/ML VERSUS THE BASELINE MEAN OF 12.23 UG/ML. 24 MARCH 2024 VITROS TDM PV3 RESULT OF 31.8 UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. 25 MARCH 2024: VITROS TDM PV3 RESULT 31.4 UG/ML VERSUS THE MIDPOINT OF THE ROM 25.9 UG/ML. 25 MARCH 2024: VITROS TDM PV3 RESULTS >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, 31.9, 34.8, 34.3, 33.5, AND 34.3 UG/ML UG/ML VERSUS THE MIDPOINT OF THE RANGE OF MEANS 25.9 UG/ML. 01 APRIL 2024: VITROS BIORAD MULTIQUAL UNASSAYED QC LOT 92963 VITROS PHYT RESULTS 32.0, 31.4, 31.6, 32.0, 31.7, 31.1, 32.0, 32.1, 30.8, 31.7, 32.5, 30.6, 31.7, 32.1, 31.1, 31.2, AND 31.6 UG/ML VERSUS THE CUSTOMER BASELINE MEAN 25.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159786 ↗
Other ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN devices
- ONLINE TDM Phenytoin 08445567190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.