VITROS 6802584Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10758750002849), received between Dec 2, 2022 and Sep 18, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026High Test Results; Non Reproducible Results

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report a non-reproducible, higher than expected VITROS Creatinine (CREA) result was obtained from a single patient sample tested using VITROS CREA slide lot 1520-3584-1928 on a VITROS XT3400 Chemistry System. Patient sample VITROS CREA result of 172 umol/L vs. the expected result of 76 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 VITROS CREA result was reported outside of the laboratory. No corrected report was issued at this time. However, it was confirmed that no treatment was stopped/ started or altered based on the higher than expected result. There was no allegation of patient harm as a result of the event. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615780.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817035 ↗
• MalfunctionAug 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497847 ↗
• MalfunctionApr 14, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CHEMISTRY PRODUCTS CREATININE (CREA) RESULTS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS XT3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLE ON AN ALTERNATE NON-VITROS CREATININE METHOD. PATIENT VITROS CREA RESULTS OF 1.60 AND 1.60 MG/DL VS THE EXPECTED RESULT OF 0.96 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872181 ↗
• MalfunctionApr 14, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CHEMISTRY PRODUCTS CREATININE (CREA) RESULTS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS XT3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLE ON AN ALTERNATE NON-VITROS CREATININE METHOD. PATIENT VITROS CREA RESULTS OF 1.60 AND 1.60 MG/DL VS THE EXPECTED RESULT OF 0.96 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS 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 24872177 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLES ON AN ALTERNATE (ROCHE) METHOD. VITROS 56004614 (J1): PATIENT 3 RESULT OF 1.90 MG/DL VS THE EXPECTED RESULT OF 1.15 MG/DL PATIENT 5 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.13 MG/DL PATIENT 6 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.25 MG/DL PATIENT 2 (SAMPLE 2) RESULT OF 1.57 MG/DL VS ROCHE 0.99 VITROS 56004676 (J2): PATIENT 1 RESULT OF 1.60 AND 2.20 MG/DL MG/DL VS THE EXPECTED RESULT OF 1.21 MG/DL PATIENT 2 (SAMPLE 1) RESULT OF 2.40 MG/DL VS THE EXPECTED RESULT OF 0.85 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, CORRECTED REPORTS WERE LATER ISSUED. IT REMAINS UNKNOWN IF TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791930 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLES ON AN ALTERNATE (ROCHE) METHOD. VITROS 56004614 (J1): PATIENT 3 RESULT OF 1.90 MG/DL VS THE EXPECTED RESULT OF 1.15 MG/DL PATIENT 5 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.13 MG/DL PATIENT 6 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.25 MG/DL PATIENT 2 (SAMPLE 2) RESULT OF 1.57 MG/DL VS ROCHE 0.99 VITROS 56004676 (J2): PATIENT 1 RESULT OF 1.60 AND 2.20 MG/DL MG/DL VS THE EXPECTED RESULT OF 1.21 MG/DL PATIENT 2 (SAMPLE 1) RESULT OF 2.40 MG/DL VS THE EXPECTED RESULT OF 0.85 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, CORRECTED REPORTS WERE LATER ISSUED. IT REMAINS UNKNOWN IF TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791922 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLES ON AN ALTERNATE (ROCHE) METHOD. VITROS 56004614 (J1): PATIENT 3 RESULT OF 1.90 MG/DL VS THE EXPECTED RESULT OF 1.15 MG/DL PATIENT 5 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.13 MG/DL PATIENT 6 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.25 MG/DL PATIENT 2 (SAMPLE 2) RESULT OF 1.57 MG/DL VS ROCHE 0.99 VITROS 56004676 (J2): PATIENT 1 RESULT OF 1.60 AND 2.20 MG/DL MG/DL VS THE EXPECTED RESULT OF 1.21 MG/DL PATIENT 2 (SAMPLE 1) RESULT OF 2.40 MG/DL VS THE EXPECTED RESULT OF 0.85 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, CORRECTED REPORTS WERE LATER ISSUED. IT REMAINS UNKNOWN IF TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791917 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLES ON AN ALTERNATE (ROCHE) METHOD. VITROS 56004614 (J1): PATIENT 3 RESULT OF 1.90 MG/DL VS THE EXPECTED RESULT OF 1.15 MG/DL PATIENT 5 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.13 MG/DL PATIENT 6 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.25 MG/DL PATIENT 2 (SAMPLE 2) RESULT OF 1.57 MG/DL VS ROCHE 0.99 VITROS 56004676 (J2): PATIENT 1 RESULT OF 1.60 AND 2.20 MG/DL MG/DL VS THE EXPECTED RESULT OF 1.21 MG/DL PATIENT 2 (SAMPLE 1) RESULT OF 2.40 MG/DL VS THE EXPECTED RESULT OF 0.85 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, CORRECTED REPORTS WERE LATER ISSUED. IT REMAINS UNKNOWN IF TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791868 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLES ON AN ALTERNATE (ROCHE) METHOD. VITROS 56004614 (J1): PATIENT 3 RESULT OF 1.90 MG/DL VS THE EXPECTED RESULT OF 1.15 MG/DL PATIENT 5 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.13 MG/DL PATIENT 6 RESULT OF 1.70 MG/DL VS THE EXPECTED RESULT OF 1.25 MG/DL PATIENT 2 (SAMPLE 2) RESULT OF 1.57 MG/DL VS ROCHE 0.99 VITROS 56004676 (J2): PATIENT 1 RESULT OF 1.60 AND 2.20 MG/DL MG/DL VS THE EXPECTED RESULT OF 1.21 MG/DL PATIENT 2 (SAMPLE 1) RESULT OF 2.40 MG/DL VS THE EXPECTED RESULT OF 0.85 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, CORRECTED REPORTS WERE LATER ISSUED. IT REMAINS UNKNOWN IF TREATMENT WAS STARTED, STOPPED, OR ALTERED IN ANY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791851 ↗
• MalfunctionMar 26, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS WHEN PROCESSING VITROS CREA LOT 1515-3583-9180 ON A VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM ONE OF THE PATIENT SAMPLES WHEN PROCESSING VITROS CREA LOT 1545-3582-6933 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED USING AN UNKNOWN METHOD AT AN EMERGENCY ROOM. VITROS XT 7600 INTEGRATED SYSTEM, S/N (B)(6) (J1) VITROS CREA LOT 1515-3583-9180: PATIENT 1 VITROS CREA RESULT OF 2.33 MG/DL VS. THE EXPECTED RESULT OF 0.86 MG/DL PATIENT 2 VITROS CREA RESULTS OF 3.14, 3.31, 3.07, 3.01, 2.99, 3.00, 2.86 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL XT 3400 CHEMISTRY SYSTEM, S/N (B)(6) (J2) USING VITROS CREA LOT 1545-3582-6933: PATIENT 2 VITROS CREA RESULTS OF 2.96 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706429 ↗
• MalfunctionMar 26, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS WHEN PROCESSING VITROS CREA LOT 1515-3583-9180 ON A VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM ONE OF THE PATIENT SAMPLES WHEN PROCESSING VITROS CREA LOT 1545-3582-6933 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED USING AN UNKNOWN METHOD AT AN EMERGENCY ROOM. VITROS XT 7600 INTEGRATED SYSTEM, S/N (B)(6) (J1) VITROS CREA LOT 1515-3583-9180: PATIENT 1 VITROS CREA RESULT OF 2.33 MG/DL VS. THE EXPECTED RESULT OF 0.86 MG/DL PATIENT 2 VITROS CREA RESULTS OF 3.14, 3.31, 3.07, 3.01, 2.99, 3.00, 2.86 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL XT 3400 CHEMISTRY SYSTEM, S/N 34500176 (J2) USING VITROS CREA LOT 1545-3582-6933: PATIENT 2 VITROS CREA RESULTS OF 2.96 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706400 ↗
• MalfunctionMar 26, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS WHEN PROCESSING VITROS CREA LOT: 1515-3583-9180 ON A VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM ONE OF THE PATIENT SAMPLES WHEN PROCESSING VITROS CREA LOT: 1545-3582-6933 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED USING AN UNKNOWN METHOD AT AN EMERGENCY ROOM. VITROS XT 7600 INTEGRATED SYSTEM, S/N: (B)(6) (J1) VITROS CREA LOT: 1515-3583-9180: PATIENT 1 VITROS CREA RESULT OF 2.33 MG/DL VS. THE EXPECTED RESULT OF 0.86 MG/DL PATIENT 2 VITROS CREA RESULTS OF 3.14, 3.31, 3.07, 3.01, 2.99, 3.00, 2.86 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL XT 3400 CHEMISTRY SYSTEM, S/N: (B)(6) (J2) USING VITROS CREA LOT: 1545-3582-6933: PATIENT 2 VITROS CREA RESULTS OF 2.96 MG/DL VS. THE EXPECTED RESULT OF 1.23 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706388 ↗
• MalfunctionMar 17, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED VITROS CREA RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREATININE (CREA) SLIDES LOT 1514-3574-2368 ON A VITROS 350 CHEMISTRY SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS ABBOTT ARCHITECT METHOD RESULT OBTAINED USING THE SAME SAMPLE. PATIENT SAMPLE VITROS CREA RESULT OF 142 UMOL/L (DILUTED) VERSUS AN EXPECTED RESULT OF 71 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 VITROS CREA RESULT OF 142 UMOL/L WAS REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. A CORRECTED REPORT OF 71 UMOL/L WAS LATER ISSUED FOR THE PATIENT. 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 24617219 ↗
• MalfunctionMar 3, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS CREA RESULT OF 12 MG/DL VS. THE EXPECTED RESULT OF 0.90 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 24500707 ↗
• MalfunctionDec 18, 2025Low Test Results; Low Test Results

  ON 04 DECEMBER 2025, A DISTRIBUTOR CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF THE CUSTOMER TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREA RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES ON A VITROS 4600 CHEMISTRY SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO A NON-VITROS KYOTO TMS-1024I METHOD RESULT OBTAINED FROM THE SAME SAMPLE. PATIENT VITROS CREA RESULT OF 0.36 MG/DL VERSUS AN EXPECTED RESULT OF 3.42 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREA RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843273 ↗
• MalfunctionNov 20, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 4600 CHEMISTRY SYSTEM AND A VITROS 250 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING THE SAME PATIENT SAMPLE ON AN ALTERNATE, UNKNOWN METHOD. VITROS 4600 CHEMISTRY SYSTEM PATIENT SAMPLE 1 RESULTS OF 2.18 AND 2.90 MG/DL VERSUS THE EXPECTED RESULT OF 0.96 MG/DL VITROS 250 CHEMISTRY SYSTEM PATIENT SAMPLE 1 RESULT OF 2.42 MG/DL VERSUS THE EXPECTED RESULT OF 0.96 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609941 ↗
• MalfunctionOct 24, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM THREE DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT 3400 CHEMISTRY SYSTEM WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING DIFFERENT SAMPLES FROM THE SAME COLLECTION FROM THE SAME PATIENTS TESTED ON A NON-VITROS BECKMAN COULTER AU5800. VITROS CREA SLIDE LOT 7219-0018-5809: PATIENT SAMPLE 2 VITROS CREA RESULTS OF 2.04 AND 1.95 MG/DL VS. THE EXPECTED RESULT OF 1.13 MG/DL. VITROS CREA SLIDE LOT 7222-0021-3935: PATIENT SAMPLE 3 VITROS CREA RESULT OF 1.60 MG/DL VS. THE EXPECTED RESULT OF 0.95 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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) AND R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383498 ↗
• MalfunctionOct 24, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM THREE DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT 3400 CHEMISTRY SYSTEM WHEN COMPARED TO RESULTS OBTAINED FROM PROCESSING DIFFERENT SAMPLES FROM THE SAME COLLECTION FROM THE SAME PATIENTS TESTED ON A NON-VITROS BECKMAN COULTER AU5800. VITROS CREA SLIDE LOT 7219-0018-5809: PATIENT SAMPLE 2 VITROS CREA RESULTS OF 2.04 AND 1.95 MG/DL VS. THE EXPECTED RESULT OF 1.13 MG/DL VITROS CREA SLIDE LOT 7222-0021-3935: PATIENT SAMPLE 3 VITROS CREA RESULT OF 1.60 MG/DL VS. THE EXPECTED RESULT OF 0.95 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREA RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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) AND REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383491 ↗
• MalfunctionAug 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS CREA RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE 2 VITROS CREA RESULTS OF 0.39, 0.42, 0.49, 0.56, 0.58, 0.57, 0.56, 0.58, AND 0.74 MG/DL VS. THE EXPECTED RESULT OF 5.28 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER STATED THAT ALL OF VITROS CREA RESULTS FROM THE ON (B)(6) 2025 (INCLUDING THE LOWER-THAN-EXPECTED RESULTS OF 0.39 AND 0.42) WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMINISTERED TREATMENT AFTER PATIENT SAMPLE 1 WAS COLLECTED FROM THE ED PRIOR TO THE DRAW OF PATIENT SAMPLE 2; HOWEVER, THE TREATMENT WAS BASED ON THE SYMPTOMS OF THE PATIENT AND NOT ON THE VITROS CREA PATIENT SAMPLE 1 RESULT OBTAINED (WHICH WAS THE EXPECTED RESULT). NO TREATMENT WAS ALTERED BASED ON THE LOWER-THAN-EXPECTED PATIENT SAMPLE 2 RESULTS OBTAINED LATER FROM THE HOSPITAL WARD. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892940 ↗
• MalfunctionJul 16, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS CREA RESULTS OF 180.9 AND 188.8 UMOL/L VS. THE EXPECTED ROCHE CREATININE RESULT OF 70.0 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 VITROS CREA RESULTS OF 180.9 AND 188.8 UMOL/L WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 32282912 AND REPORTABILITY ASSESSMENT 611401.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521878 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CREA SLIDE LOT 1515-3572-0380 WHEN TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT 1 SAMPLE 1 VITROS CREA RESULT OF 2.08 MG/DL VS. THE EXPECTED RESULT OF 0.39 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS CREA RESULT OF 2.08 MG/DL WAS REPORTED TO THE CLINICIAN, HOWEVER, THE RESULT WAS QUESTIONED BY THE CLINICIAN. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED, HOWEVER IT WAS CONFIRMED THAT NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON THE REPORTED VITROS CREA RESULT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 22283107 ↗
• 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 A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE AND A LOWER THAN EXPECTED VITROS CREA QUALITY CONTROL (QC) RESULT WERE OBTAINED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1545-3561-6492 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF 2.5 MG/DL VS. THE EXPECTED RESULT OF 0.6 MG/DL BIORAD LEVEL 1 QC (LOT 89750) RESULT OF 1.17 MG/DL VS. THE EXPECTED RESULT OF 1.67 MG/DL 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 CREA RESULT WAS PROCESSED USING A NON-PATIENT QUALITY CONTROL MATERIAL. THE HIGHER THAN EXPECTED VITROS CREA PATIENT RESULT WAS REPORTED FROM THE LABORATORY. THE CLINICIAN QUESTIONED THE CREA RESULT AND REPEAT TESTING OCCURRED. A CORRECTED REPORT WAS ISSUED FOR A CREA RESULT MORE ALIGNED TO THE PATIENTS CLINICAL PICTURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO CHANGE IN TREATMENT PLAN FOR THE PATIENT DUE TO THE ERRONEOUS RESULT THAT WAS RELEASED. THERE WERE NO ALLEGATIONS OF PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761253 ↗
• 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 A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE; AND A LOWER THAN EXPECTED VITROS CREA QUALITY CONTROL (QC) RESULT WERE OBTAINED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1545-3561-6492 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF 2.5 MG/DL VS. THE EXPECTED RESULT OF 0.6 MG/DL BIORAD LEVEL 1 QC (LOT 89750) RESULT OF 1.17 MG/DL VS. THE EXPECTED RESULT OF 1.67 MG/DL 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 CREA RESULT WAS PROCESSED USING A NON-PATIENT QUALITY CONTROL MATERIAL. THE HIGHER THAN EXPECTED VITROS CREA PATIENT RESULT WAS REPORTED FROM THE LABORATORY. THE CLINICIAN QUESTIONED THE CREA RESULT AND REPEAT TESTING OCCURRED. A CORRECTED REPORT WAS ISSUED FOR A CREA RESULT MORE ALIGNED TO THE PATIENTS CLINICAL PICTURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO CHANGE IN TREATMENT PLAN FOR THE PATIENT DUE TO THE ERRONEOUS RESULT THAT WAS RELEASED. THERE WERE NO ALLEGATIONS OF PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761228 ↗
• MalfunctionMar 12, 2025High Test Results; High Test Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) EMPLOYEE BECAME AWARE OF AN ARTICLE PUBLISHED IN GAIMS JOURNAL OF MEDICAL SCIENCES THAT DOCUMENTED HOW PROLONGED STORAGE OF SAMPLES CAN RESULT IN CHANGES TO ROUTINE BIOCHEMICAL PARAMETERS. HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM A PATIENT SAMPLE POOL TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AFTER STORAGE AT -20C FOR 15 DAYS, 1 MONTH, 2 MONTHS AND 3 MONTHS. PATIENT POOL VITROS CREA RESULTS OF 1.51 (15 DAYS), 1.80 (1 MONTH), 1.80 (2 MONTHS) AND 2.0 (3 MONTHS) MG/DL VS. THE EXPECTED TIME 0 VITROS CREA RESULT OF 0.70 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED PATIENT SAMPLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN 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 21583655 ↗
• MalfunctionMar 5, 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 VITROS CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1545-3561-6410 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS CREA RESULT OF 0.90 MG/DL VERSUS AN EXPECTED RESULT OF 3.32 MG/DL 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 CREA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULT, AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. A CORRECTED REPORT WAS LATER ISSUED FOR THE PATIENT. 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 21525911 ↗