VITROS 6801709Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10758750006731), received between Jan 23, 2023 and Mar 3, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (22 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. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1833-2025 · Root cause: Storage · 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.

• MalfunctionMar 3, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS VANCOMYCIN (VANC) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS VANC REAGENT LOT 2514-57-3611 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE PATIENT SAMPLE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED FROM TESTING THE SAME PATIENT SAMPLE ON AN ALTERNATE NON-VITROS SIEMENS METHODOLOGY. PATIENT SAMPLE 18 VITROS VANC RESULTS OF 8.60 UG/ML VS. THE EXPECTED RESULT OF 17.4 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 VITROS VANC RESULT WAS OBTAINED AS PART OF PATIENT CORRELATION TESTING AND WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN 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 24500144 ↗
• MalfunctionJan 21, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS VANC REAGENT LOT 2514-57-3336 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE PATIENT SAMPLE RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED FROM TESTING THE SAME PATIENT SAMPLE ON AN ALTERNATE (UNKNOWN) METHODOLOGY. PATIENT 1 SAMPLE VITROS VANC RESULTS OF 7.81, 7.80, AND 6.75 UG/ML VS. THE EXPECTED RESULT OF 66.7 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 VITROS VANC RESULTS OBTAINED FROM TEST EVENT 1 AND TEST EVENT 2 WERE REPORTED FROM THE LABORATORY. THE PHARMACY QUESTIONED THE LOWER THAN EXPECTED VITROS VANC RESULTS AND TESTING USING AN ALTERNATE METHODOLOGY WAS REQUESTED. THE CUSTOMER MADE THE ALLEGATION THAT VANCOMYCIN TREATMENT WAS ADMINISTERED TO THE AFFECTED PATIENT AS A RESULT OF THE LOW VITROS VANC RESULTS WHERE IT MAY HAVE OTHERWISE NOT BEEN ADMINISTERED. IT IS UNKNOWN WHETHER OR NOT CORRECTED REPORTS WERE ISSUED FOR ANY O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135721 ↗
• MalfunctionJan 16, 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 PATIENT SAMPLES AND A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS LOT 1003930 CONTROL USING VITROS VANCOMYCIN (VANC) REAGENT LOT 2514-57-3336 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULTS OF 9.23 UG/ML VS. THE EXPECTED RESULT OF 16.35 UG/ML PATIENT SAMPLE 2 RESULT OF 8.76 UG/ML VS. THE EXPECTED RESULT OF 15.07 UG/ML BIORAD LEVEL 2 CONTROL RESULTS OF 8.70 AND 7.37 UG/ML VS. THE BASELINE MEAN RESULT OF 16.47 UG/ML. THE LOWER THAN EXPECTED VITROS VANC PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THE RESULTS WERE QUESTIONED BY THE HOSPITAL PHARMACY. CORRECTED REPORTS WERE ISSUED AND 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100945 ↗
• MalfunctionJan 16, 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 PATIENT SAMPLES AND A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS LOT 1003930 CONTROL USING VITROS VANCOMYCIN (VANC) REAGENT LOT 2514-57-3336 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULTS OF 9.23 UG/ML VS. THE EXPECTED RESULT OF 16.35 UG/ML PATIENT SAMPLE 2 RESULT OF 8.76 UG/ML VS. THE EXPECTED RESULT OF 15.07 UG/ML BIORAD LEVEL 2 CONTROL RESULTS OF 8.70 AND 7.37 UG/ML VS. THE BASELINE MEAN RESULT OF 16.47 UG/ML. THE LOWER THAN EXPECTED VITROS VANC PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THE RESULTS WERE QUESTIONED BY THE HOSPITAL PHARMACY. CORRECTED REPORTS WERE ISSUED AND 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100941 ↗
• MalfunctionDec 15, 2025Low 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 A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK TDM CONTROLS, LOT 1002900 AND FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS VANC LOT 2514-57-3072 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. NON-VITROS BIORAD LEVEL 3 CONTROL RESULT OF <5 UG/ML VS. THE EXPECTED RESULT OF 30.30 UG/ML PATIENT 1 SAMPLE VITROS VANC RESULTS OF <5 AND <5 UG/ML VS. THE EXPECTED RESULT OF 16.87 UG/ML PATIENT 2 SAMPLE VITROS VANC RESULTS OF <5 AND <5 UG/ML VS. THE EXPECTED RESULT OF 21.84 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 VITROS VANC RESULTS OBTAINED FROM THE PATIENT 1 AND PATIENT 2 SAMPLES WERE 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 23801886 ↗
• MalfunctionNov 3, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-57-3198 ON A VITROS 5600 INTEGRATED SYSTEM. MAS LOT CHU2512 LEVEL 3 VITROS VANC RESULTS OF <5 AND <5 UG/ML VS AN EXPECTED RESULT OF 29.86 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 VANC RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 23457843 ↗
• MalfunctionApr 3, 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 VANC RESULTS WERE OBTAINED FROM A TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM PV I LOT C2150 RESULTS OF 15.55, 15.42, 19.99 AND 20.49 UG/ML VS. THE BASELINE MEAN OF 7.73 UG/ML VITROS TDM PV III LOT E2152 RESULTS OF <5.0, <5.0, <5.0, <5.0 UG/ML AND 7.44 UG/ML VS. THE BASELINE MEAN OF 32.0 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. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS 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 NUMBERS (B)(4) AND RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761206 ↗
• MalfunctionApr 3, 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 VANC RESULTS WERE OBTAINED FROM A TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM PV I LOT C2150 RESULTS OF 15.55, 15.42, 19.99 AND 20.49 UG/ML VS. THE BASELINE MEAN OF 7.73 UG/ML VITROS TDM PV III LOT E2152 RESULTS OF <5.0, <5.0, <5.0, <5.0 UG/ML AND 7.44 UG/ML VS. THE BASELINE MEAN OF 32.0 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. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS 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 NUMBERS (B)(4) AND RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761193 ↗
• MalfunctionMar 10, 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 THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID AND A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT: 2514-56-2737 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT: 85360 LEVEL 2 RESULTS OF 9.88, 9.89, 9.95 AND 9.89 UG/ML VS AN EXPECTED RESULT OF 16.35 UG/ML VITROS TDM PV I LOT: C2150 RESULT OF 16.07 UG/ML VS AN EXPECTED RESULT OF 7.5 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 VITROS VANC RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED USING THE AFFECTED VITROS VANC REAGENT LOT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO REPORTED ALLEGAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559421 ↗
• MalfunctionMar 10, 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 THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID AND A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-56-2737 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85360 LEVEL 2 RESULTS OF 9.88, 9.89, 9.95 AND 9.89 UG/ML VS AN EXPECTED RESULT OF 16.35 UG/ML VITROS TDM PV I LOT C2150 RESULT OF 16.07 UG/ML VS AN EXPECTED RESULT OF 7.5 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 VITROS VANC RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED USING THE AFFECTED VITROS VANC REAGENT LOT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO REPORTED ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559267 ↗
• MalfunctionJan 14, 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 VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS VANC REAGENT TESTED ON A VITROS 5600 INTEGRATED SYSTEM. (B)(6) 2024: MAS LEVEL 1 QC (LOT TDA2508) RESULT OF > 50.0 UG/ML VERSUS THE EXPECTED RESULT OF 4.808 UG/ML, (B)(6) 2024: MAS LEVEL 2 QC (LOT TDA2508) RESULT OF 9.120 UG/ML VERSUS THE EXPECTED RESULT OF 24.142 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. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. 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) AND REPORTABILITY ASSESSMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154171 ↗
• MalfunctionJan 14, 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 VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS VANC REAGENT TESTED ON A VITROS 5600 INTEGRATED SYSTEM. ON (B)(6) 2024: MAS LEVEL 1 QC (LOT TDA2508) RESULT OF > 50.0 UG/ML VERSUS THE EXPECTED RESULT OF 4.808 UG/ML ON (B)(6) 2024: MAS LEVEL 2 QC (LOT TDA2508) RESULT OF 9.120 UG/ML VERSUS THE EXPECTED RESULT OF 24.142 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. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. 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) AND REPORTABILITY ASSES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153456 ↗
• 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 XT7600 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 20066715 ↗
• MalfunctionJul 11, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III, LOT B1736 AND A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL, LOT 85360 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS TDM PV III LOT B1736 RESULTS OF <5.0 UG/ML (X3) VS. THE BASELINE MEAN OF 32.7 UG/ML BIORAD LOT 85360 LEVEL 3 RESULT OF <5.0 UG/ML VS. THE TARGET VALUE OF 27.03 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722300 ↗
• MalfunctionJul 11, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III, LOT B1736 AND A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL, LOT 85360 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS TDM PV III LOT B1736 RESULTS OF <5.0 UG/ML (X3) VS. THE BASELINE MEAN OF 32.7 UG/ML BIORAD LOT 85360 LEVEL 3 RESULT OF <5.0 UG/ML VS. THE TARGET VALUE OF 27.03 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722209 ↗
• MalfunctionMar 28, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM ONE LEVEL OF A NON VITROS BIORAD QUALITY CONTROL FLUID AND FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS WHEN USING VITROS VANC LOT 2514-53-1873 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. 56002673: BIORAD LEVEL 2 LOT 92962 RESULTS OF <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 33.499 UG/ML VITROS TDM PVII LOT A1735 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 20.9 UG/ML VITROS TDM PVIII LOT X1172 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 41.5 UG/ML 46000263: BIORAD LEVEL 2 LOT 92962 RESULT <5.0 VERSUS THE EXPECTED RESULT OF 33.499 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 RESULTS OCCURRED ON QUALITY CONTROL FLUIDS. NO NEW PATIENT SAMPLES WERE PROCESSED, AS VANC QUALITY CONTROL RESULTS WERE LOW OUTSIDE THE ESTABLISHED RANGES. THERE WAS NO ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999198 ↗
• MalfunctionMar 28, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM ONE LEVEL OF A NON VITROS BIORAD QUALITY CONTROL FLUID AND FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS WHEN USING VITROS VANC LOT 2514-53-1873 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. 56002673: BIORAD LEVEL 2 LOT 92962 RESULTS OF <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 33.499 UG/ML VITROS TDM PVII LOT A1735 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 20.9 UG/ML VITROS TDM PVIII LOT X1172 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 41.5 UG/ML 46000263: BIORAD LEVEL 2 LOT 92962 RESULT <5.0 VERSUS THE EXPECTED RESULT OF 33.499 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 RESULTS OCCURRED ON QUALITY CONTROL FLUIDS. NO NEW PATIENT SAMPLES WERE PROCESSED, AS VANC QUALITY CONTROL RESULTS WERE LOW OUTSIDE THE ESTABLISHED RANGES. THERE WAS NO ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998577 ↗
• MalfunctionMar 28, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM ONE LEVEL OF A NON VITROS BIORAD QUALITY CONTROL FLUID AND FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS WHEN USING VITROS VANC LOT 2514-53-1873 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. 56002673: BIORAD LEVEL 2 LOT 92962 RESULTS OF <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 33.499 UG/ML VITROS TDM PVII LOT A1735 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 20.9 UG/ML VITROS TDM PVIII LOT X1172 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 41.5 UG/ML 46000263: BIORAD LEVEL 2 LOT 92962 RESULT <5.0 VERSUS THE EXPECTED RESULT OF 33.499 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 RESULTS OCCURRED ON QUALITY CONTROL FLUIDS. NO NEW PATIENT SAMPLES WERE PROCESSED, AS VANC QUALITY CONTROL RESULTS WERE LOW OUTSIDE THE ESTABLISHED RANGES. THERE WAS NO ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998446 ↗
• MalfunctionMar 28, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM ONE LEVEL OF A NON VITROS BIORAD QUALITY CONTROL FLUID AND FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS WHEN USING VITROS VANC LOT 2514-53-1873 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. 56002673: BIORAD LEVEL 2 LOT 92962 RESULTS OF <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 33.499 UG/ML VITROS TDM PVII LOT A1735 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 20.9 UG/ML VITROS TDM PVIII LOT X1172 RESULTS OF <5.0, <5.0, <5.0 AND <5.0 VERSUS THE EXPECTED RESULT OF 41.5 UG/ML 46000263: BIORAD LEVEL 2 LOT 92962 RESULT <5.0 VERSUS THE EXPECTED RESULT OF 33.499 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 RESULTS OCCURRED ON QUALITY CONTROL FLUIDS. NO NEW PATIENT SAMPLES WERE PROCESSED, AS VANC QUALITY CONTROL RESULTS WERE LOW OUTSIDE THE ESTABLISHED RANGES. THERE WAS NO ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997374 ↗
• MalfunctionDec 18, 2023Low 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 VITROS VANCOMYCIN (VANC) RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE ON A VITROS XT7600 SYSTEM WHEN COMPARED WITH THE REPEAT RESULT. VITROS VANC RESULT OF <5 UG/ML VERSUS THE REPEAT VITROS VANC RESULT OF 25.4 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 VITROS VANC RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND A CORRECTED REPORT WAS LATER ISSUED. THERE WAS NO REPORTED ALLEGATION OF 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 18348079 ↗
• MalfunctionJun 27, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-51-1301 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 103.04 MG/L (UG/ML) VS AN EXPECTED RESULT OF 37.24 MG/L (UG/ML) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED RESULT WAS REPORTED OUT OF THE LABORATORY, HOWEVER, A PHYSICIAN QUESTIONED THE RESULT AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. A REDRAW SAMPLE WAS OBTAINED FROM THE PATIENT AND A CORRECTED RESULT REPORT WAS LATER ISSUED. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 17208218 ↗
• MalfunctionJan 23, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS LOT: CHA24080 CONTROL FLUIDS AND THE RESULTS OBTAINED FROM THE LEVEL 2 CONTROL MET POTENTIAL HEALTH AND SAFETY CRITERIA. THE RESULTS WERE OBTAINED ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LEVEL 2 RESULTS OF <5.0 UG/ML (X3) VS. THE TARGET VALUE OF 32.0 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY, THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225284 ↗
• MalfunctionJan 23, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS LOT: CHA24080 CONTROL FLUIDS AND THE RESULTS OBTAINED FROM THE LEVEL 2 CONTROL MET POTENTIAL HEALTH AND SAFETY CRITERIA. THE RESULTS WERE OBTAINED ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LEVEL 2 RESULTS OF <5.0 UG/ML (X3) VS. THE TARGET VALUE OF 32.0 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY, THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225265 ↗