VITROS 8221384Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10758750004560), received between May 4, 2023 and Jun 1, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (CAP) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS: 2520-0118-1165 AND 2517-0117-4553 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT: 2517-0117-4553 (LOT: 1) CAP SAMPLE CHM-02 INITIAL VITROS PHBR RESULT OF 57.66 UG/ML VS. THE CAP PEER TARGET OF 75.7 UG/ML VITROS PHBR LOT: 2520-0118-1165 (LOT: 2) CAP SAMPLE CHM-02 REPEAT VITROS PHBR RESULT OF 53.57 UG/ML VS. THE CAP PEER TARGET OF 75.7 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 PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352447 ↗
• MalfunctionJun 1, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (CAP) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS 2520-0118-1165 AND 2517-0117-4553 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT 2517-0117-4553 (LOT 1) CAP SAMPLE CHM-02 INITIAL VITROS PHBR RESULT OF 57.66 UG/ML VS. THE CAP PEER TARGET OF 75.7 UG/ML VITROS PHBR LOT 2520-0118-1165 (LOT 2) CAP SAMPLE CHM-02 REPEAT VITROS PHBR RESULT OF 53.57 UG/ML VS. THE CAP PEER TARGET OF 75.7 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 PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4), (B)(4) AND REPORTAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351915 ↗
• MalfunctionMar 31, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS 2517-0117-7418 AND 2517-0117-7396 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT 2517-0117-7396 (LOT 1) INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 46.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML VITROS PHBR LOT 2517-0117-7418 (LOT 2) INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULTS OF 46.6, 49.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML NEW API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 42.4 UG/ML VS. THE API PEER TARGET OF 62.3 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 LOWER-THAN-EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746600 ↗
• MalfunctionMar 31, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS 2517-0117-7418 AND 2517-0117-7396 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT 2517-0117-7396 (LOT 1): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 46.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML VITROS PHBR LOT 2517-0117-7418 (LOT 2): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULTS OF 46.6, 49.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML NEW API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 42.4 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746592 ↗
• MalfunctionMar 31, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS: 2517-0117-7418 AND 2517-0117-7396 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT: 2517-0117-7396 (LOT: 1): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 46.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML VITROS PHBR LOT: 2517-0117-7418 (LOT: 2): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULTS OF 46.6, 49.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML NEW API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 42.4 UG/ML VS. THE API PEER TARGET OF 62.3 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 LOWER-THAN-EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746586 ↗
• MalfunctionMar 31, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOTS: 2517-0117-7418 AND 2517-0117-7396 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT: 2517-0117-7396 (LOT 1): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 46.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML VITROS PHBR LOT: 2517-0117-7418 (LOT: 2): INITIAL API PROFICIENCY SAMPLE VITROS PHBR RESULTS OF 46.6, 49.0 UG/ML VS. THE API PEER TARGET OF 62.3 UG/ML NEW API PROFICIENCY SAMPLE VITROS PHBR RESULT OF 42.4 UG/ML VS. THE API PEER TARGET OF 62.3 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 LOWER-THAN-EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746582 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED PHENOBARBITAL (PHBR) RESULT WAS OBTAINED FROM A NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT 2511-0107-8274 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR BIORAD LEVEL 1 LOT 85360 RESULT OF 13.56 UG/ML VERSUS THE EXPECTED RESULT OF 10.55 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 QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. 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 20149962 ↗
• 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 TWO OF THREE MDR¿S FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868583 ↗
• 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 ONE OF THREE MDR¿S FOR THIS EVENT. THR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868540 ↗