VITROS 1896836Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750000203), received between Mar 15, 2023 and Jul 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Low Test Results

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report lower than expected VITROS CKMB results obtained from three patient samples tested using VITROS Immunodiagnostic Products CK-MB reagent lot 4010 on a VITROS XT 7600 Integrated System when compared to results from the same samples tested using VITROS CKMB reagent lot 3980. Correlation Sample 1 VITROS CKMB result of 2.31 ng/mL vs. the expected result of 4.98 ng/mL. Correlation Sample 2 VITROS CKMB result of 3.35 ng/mL vs. the expected result of 5.29 ng/mL. Correlation Sample 6 VITROS CKMB result of 2.34 ng/mL vs. the expected result of 5.29 ng/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 CKMB results were not reported from the laboratory as they were generated during a lot to lot correlation. 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 615283.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50055653 ↗
• MalfunctionApr 16, 2026High Test Results; Non Reproducible Results

  A FIELD APPLICATION SPECIALIST (FAS), ON BEHALF OF A CUSTOMER, CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED CK-MB RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT LOT 3980 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 100.0 NG/ML VS. THE EXPECTED RESULT OF 0.42 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS CK-MB RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS 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 24895705 ↗
• MalfunctionOct 17, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED CK-MB RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT LOT 3710 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 40.405 AND 41.342 NG/ML VS. THE EXPECTED RESULT OF 0.551 NG/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 VITROS CK-MB PATIENT SAMPLE RESULT OF 40.405 NG/ML WAS REPORTED FROM THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULT AND A CORRECTED REPORT WAS LATER ISSUED. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE HIGHER-THAN-EXPECTED RESULT AND THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 20476518 ↗
• MalfunctionMar 15, 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 CKMB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS ABBOTT CKMB RESULT. PATIENT SAMPLE RESULT OF 170 NG/ML VS. THE EXPECTED RESULT OF 0.60 NG/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 VITROS CKMB RESULT WAS NOT REPORTED FROM 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 16548203 ↗