VITROS 6801710Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10758750006748), received between Dec 28, 2022 and Sep 10, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 11, 2018Terminated

   Negative bias results when using VITROS VALP Reagent, GEN 25.

   Z-0848-2019 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716432 ↗
• MalfunctionSep 10, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716411 ↗
• MalfunctionJul 31, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104447 ↗
• MalfunctionJul 31, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104419 ↗
• MalfunctionMay 28, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUIDS USING THE VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-37-3554 PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS VALP BIORAD LEVEL 1 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 42 UG/ML VITROS VALP BIORAD LEVEL 3 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 122 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 VALP RESULTS WERE OBTAINED USING QC FLUIDS. THERE WERE NO ALLEGATIONS OF HARM ASSOCIATED WITH 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319780 ↗
• MalfunctionMay 28, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUIDS USING THE VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-37-3554 PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS VALP BIORAD LEVEL 1 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 42 UG/ML VITROS VALP BIORAD LEVEL 3 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 122 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 VALP RESULTS WERE OBTAINED USING QC FLUIDS. THERE WERE NO ALLEGATIONS OF HARM ASSOCIATED WITH 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319626 ↗
• MalfunctionAug 28, 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 VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM THREE LEVELS OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-35-2886 ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS VALP BIORAD LEVEL 1 RESULTS OF 62.4, 63.2, 27.8 UG/ML VERSUS THE EXPECTED RESULT OF 38.7 UG/ML VITROS VALP BIORAD LEVEL 2 RESULTS OF 120.4, 120.9 UG/ML VERSUS THE EXPECTED RESULT OF 76.9 UG/ML VITROS VALP BIORAD LEVEL 3 RESULTS OF >150.0, >150.0 UG/ML VERSUS THE EXPECTED RESULT OF 113.8 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 FROM QUALITY CONTROL FLUIDS. THE CUSTOMER CONFIRMED THAT PATIENT RESULTS WERE NOT PROCESSED ON THE DAY OF THE EVENT. 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 22912540 ↗
• MalfunctionJun 4, 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 VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-34-2390 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL LOT 56750 CONTROL AND A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUID ON TWO DIFFERENT VITROS XT7600 SYSTEMS. J76001978 BIORAD L2 VITROS VALP RESULTS OF 538.1 AND 538.1 UMOL/L VS. THE VITROS PEER MEAN OF 448.1 UMOL/L. J76001977 BIORAD L2 VITROS VALP RESULT OF 357.8 UMOL/L VS. THE VITROS PEER MEAN OF 448.1 UMOL/L. VITROS TDM D2151 RESULT OF 398.28 UMOL/L VS. THE EXPECTED RESULT OF 517.0 UMOL/L. THE HIGHER-THAN-EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143439 ↗
• MalfunctionSep 30, 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 VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-34-2390 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 85340 LEVEL 1: 25.70, 24.52, 51.33 UG/ML VS AN EXPECTED RESULT OF 35.88 UG/ML BIORAD LOT 85340 LEVEL 2: 61.97, 62.30, 62.15, 61.68, 62.70 UG/ML VS AN EXPECTED RESULT OF 78.41 UG/ML BIORAD LOT 85340 LEVEL 3: 90.73, 90.69 UG/ML VS AN EXPECTED RESULT OF 113.56 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 FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. DUE TO THE LOW VOLUME OF VALP PATIENT TESTING AT THIS CUSTOMER SITE, IT IS UNKNOWN WHETHER OR NOT PATIENT RESULTS HAVE BEEN IMPACTED BY THIS ISSUE. HOWEVER, IT HAS BEEN CONFIRMED THAT THERE HAVE BEEN NO REPORTED ISSUES FROM THE PHYSICIANS AND NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339947 ↗
• MalfunctionSep 30, 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 VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-34-2390 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 85340 LEVEL 1: 25.70, 24.52, 51.33 UG/ML VS AN EXPECTED RESULT OF 35.88 UG/ML BIORAD LOT 85340 LEVEL 2: 61.97, 62.30, 62.15, 61.68, 62.70 UG/ML VS AN EXPECTED RESULT OF 78.41 UG/ML BIORAD LOT 85340 LEVEL 3: 90.73, 90.69 UG/ML VS AN EXPECTED RESULT OF 113.56 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 FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. DUE TO THE LOW VOLUME OF VALP PATIENT TESTING AT THIS CUSTOMER SITE, IT IS UNKNOWN WHETHER OR NOT PATIENT RESULTS HAVE BEEN IMPACTED BY THIS ISSUE. HOWEVER, IT HAS BEEN CONFIRMED THAT THERE HAVE BEEN NO REPORTED ISSUES FROM THE PHYSICIANS AND NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339194 ↗
• MalfunctionAug 26, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS AND TWO DIFFERENT PATIENT SAMPLES USING THE VITROS VALPROIC ACID (VALP) ASSAY AND ONE LEVEL OF VITROS TDM PV FLUID AND ONE DIFFERENT PATIENT SAMPLE USING THE VITROS VANCOMYCIN (VANC) ASSAY. THE AFFECTED SAMPLES WERE TESTED USING VITROS VALP REAGENT LOT 2511-32-1564 AND VITROS VANC LOT 2514-54-1972 WHICH WERE PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS VALP REAGENT LOT 2511-32-1564: VITROS TDM PV I LOT Y1734 RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 27.0 UG/ML VITROS TDM PV II LOT A1735 RESULT OF 12.2 UG/ML VS. THE EXPECTED RESULT OF 70.0 UG/ML PATIENT 1 SAMPLE VITROS VALP RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 99.9 UG/ML PATIENT 2 SAMPLE VITROS VALP RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 69.0 UG/ML VITROS VANC REAGENT LOT 2514-54-1972: VITROS TDM PV II LOT A1735 RESULT OF <5 UG/ML VS. THE EXPECTED RESULT OF 21.8 UG/ML PATIENT 4 SAMPLE VITROS VANC RESULT OF <5 UG/ML VS. THE EXPECTED RESULT OF 20.1 UG/ML BIASED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066917 ↗
• MalfunctionAug 23, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-34-2390 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) PATIENT 2 SAMPLE RESULT OF 545.10 UMOL/L VS AN EXPECTED RESULT OF 437.40 UMOL/L VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) PATIENT 4 SAMPLE RESULT OF 312.10 UMOL/L VS AN EXPECTED RESULT OF 237.10 UMOL/L PATIENT 8 SAMPLE RESULT OF 452.90 UMOL/L VS AN EXPECTED RESULT OF 365.80 UMOL/L PATIENT 9 SAMPLE RESULT OF 607.90 UMOL/L VS AN EXPECTED RESULT OF 501.80 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED RESULTS WERE FROM PATIENT SAMPLES THAT WERE PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053749 ↗
• MalfunctionJun 24, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM I LOT Y1734 RESULT OF 39.0 UG/ML VS AN EXPECTED RESULT OF 27.6 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 RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT CONFIRM WHEN REQUESTED WHETHER PATIENT SAMPLE RESULTS WERE AFFECTED OR QUESTIONED. 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 19600583 ↗
• MalfunctionMay 16, 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 HIGHER AND LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS VALP TDM PVI LOT Y1734 RESULT OF 46.5 UG/ML AND 44.0 UG/ML VERSUS THE EXPECTED RESULT OF 27.6 UG/ML VITROS VALP TDM PVIII LOT B1736 RESULT OF 94.2 UG/ML VERSUS THE EXPECTED RESULT OF 120.6 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 FROM TWO LEVELS OF VITROS QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT PATIENT SAMPLES WERE NOT PROCESSED DURING THE TIMEFRAME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331409 ↗
• MalfunctionMar 13, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUID USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS VALP TDM PV I LOT V1171 RESULT OF 37.2 VERSUS THE EXPECTED RESULT OF 25.05 (CUSTOMERS BASELINE MEAN) 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 RESULT WAS FROM A QUALITY CONTROL FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT PATIENT SAMPLES WERE NOT PROCESSED DURING THE TIMEFRAME OF THE EVENT. 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 18893769 ↗
• MalfunctionJun 29, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-31-9784 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 2 SAMPLE RESULT OF 35.95 UG/ML VS AN EXPECTED RESULT OF 49.64 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED RESULT WAS FROM A PATIENT SAMPLE THAT WAS PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ELECTED TO SEND PATIENT SAMPLES TO AN ALTERNATE SITE FOR VALP TESTING UNTIL TROUBLESHOOTING IS COMPLETE. 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 17226166 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VALP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059930 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VALP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059923 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VALP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059919 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. (B)(4) (J1) VITROS VALP REAGENT, LOT 2511-31-9557, CAP PROFICIENCY, CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY, CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY, CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY, CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY, CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML. BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML. ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3. (B)(4) (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059911 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VALP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059905 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT: 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF 10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT: 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND 10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT: 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT: 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059859 ↗
• MalfunctionDec 28, 2022High 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 VALP RESULTS WERE OBTAINED WHEN USING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND CAP PROFICIENCY FLUIDS USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000325 (J1) VITROS VALP REAGENT LOT 2511-31-9557 CAP PROFICIENCY CHM-11 SAMPLE RESULT OF 11.6 VS. THE EXPECTED RESULT OF 27.7 CAP PROFICIENCY CHM-12 SAMPLE RESULT OF 42.6 VS. THE EXPECTED RESULT OF 69.95 CAP PROFICIENCY CHM-13 SAMPLE RESULT OF <10.0 VS. THE EXPECTED RESULT OF 21.27 CAP PROFICIENCY CHM-14 SAMPLE RESULT OF 27.3 VS. THE EXPECTED RESULT OF 47.61 CAP PROFICIENCY CHM-15 SAMPLE RESULT OF 33.4 VS. THE EXPECTED RESULT OF 55.53 BIORAD LOT 85310 LEVEL 1 VALP RESULTS OF 23.2, 23.1 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 33.67 UG/ML BIORAD LOT 85310 LEVEL 3 VALP RESULTS OF 77.3, 76.3, 72.4, 83.4, 63.6, AND 83.8 UG/ML VS. THE EXPECTED RESULT OF 105.0 UG/ML ORTHO TDM PVIII LOT U9721 RESULT OF 84.4, 89.0 AND 87.7 VS. THE EXPECTED RESULT OF 114.3 J76000329 (J2) VITROS VALP REAGENT LOT 2511-31-9557 BIORAD LOT 85310 LEVEL 1 VALP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059848 ↗