VITROS 6802301Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 10758750002504), received between Nov 30, 2022 and Sep 29, 2026 — classified as 139 malfunctions.

The most frequently reported specific device problem is “High Test Results” (130 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. Jun 5, 2023Open, Classified

   Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

   Z-2357-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937421 ↗
• MalfunctionSep 23, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872206 ↗
• MalfunctionSep 21, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845383 ↗
• MalfunctionSep 17, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809874 ↗
• MalfunctionSep 15, 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 Troponin I ES (TropI ES) result was obtained from a patient sample tested on a VITROS 5600 Integrated System. Patient sample result of 0.299 ng/mL vs. the expected result of <0.012 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 TropI ES result was reported outside of the laboratory, however, the physician questioned the result and no medical treatment was started, stopped or altered based on the erroneous VITROS TropI ES result reported. A Corrected Report was issued and there was no 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 50771018 ↗
• MalfunctionMay 27, 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 TROPONIN I RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES REAGENT LOT 6390 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 0.124 NG/ML VS. THE EXPECTED RESULT OF <0.012 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 TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT 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 25302661 ↗
• MalfunctionMay 20, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK LOT 6260 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO THE RESULT FOR THE SAMPLE OBTAINED USING THE VITROS HS TROPONIN I (HSTNI) ASSAY. PATIENT SAMPLE RESULT OF 0.067 NG/ML (ABOVE THE UPPER REFERENCE INTERVAL) VS. A VITROS HSTNI RESULT OF 1.5 NG/L (BELOW THE CUTOFF FOR DETERMINATION OF ACUTE MYOCARDIAL INFARCTION) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT IS UNKNOWN IF THE DISCORDANT, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS REPORTED FROM THE LABORATORY AS THE INFORMATION WAS NOT PROVIDED UPON REQUEST. 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 25229329 ↗
• MalfunctionMay 19, 2026High Test Results

  A QUIDELORTHO (QO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT A HIGHER THAN EXPECTED VITROS TROPI ES RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK LOT 6250 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 0.345 NG/ML (ABOVE THE AMI) VS. THE REPEAT VITROS TROPI ES RESULT OF <0.012 NG/ML (<URL). 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 TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220144 ↗
• MalfunctionMay 13, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER EXPECTED TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS TROPI ES REAGENT LOT 6240 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO NON-VITROS TROPONIN I RESULTS FOR THE SAME PATIENT SAMPLE. PATIENT 1 RESULT OF 0.3 NG/ML (ABOVE THE AMI) VERSUS NON-VITROS TROPONIN I RESULTS BELOW THE AMI BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160057 ↗
• MalfunctionMay 11, 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 TROPONIN I RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK LOT: 6445 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 15.5 NG/ML VS. THE EXPECTED RESULT OF <0.012 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 TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137073 ↗
• MalfunctionApr 29, 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 TROPONIN I (TROPI) ES RESULT WAS OBTAINED FROM A PATIENT SAMPLE TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 0.230 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML 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 TROPI ES RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY, AND 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 25036054 ↗
• MalfunctionApr 10, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS TROPI ES REAGENT LOT 6240 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS TROPIES RESULT OF 0.091 NG/ML (ABOVE THE URL) VS. THE VITROS HSTNI RESULT BELOW THE URL 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 TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613971.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844236 ↗
• MalfunctionMar 6, 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 TROPONIN I RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES REAGENT LOT 6385 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 0.133 NG/ML VS. THE EXPECTED RESULT OF <0.012 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 TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. IT IS UNKNOWN IF ANY TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULT AS THE INFORMATION WAS NOT PROVIDED UPON REQUEST. A CORRECTED REPORT WAS 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 24531931 ↗
• MalfunctionMar 2, 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 TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6220 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A REPEAT OF THE SAMPLE FROM THE SAME PATIENT. PATIENT 1 VITROS TROPI ES RESULT OF 0.110 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 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 TROPI ES RESULT OF 0.110 NG/ML 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 24489844 ↗
• MalfunctionFeb 20, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES (TROPI ES) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES REAGENT LOT 6200 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 0.076 AND 0.075 NG/ML VS. THE EXPECTED RESULT OF 0.030 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 TROPI ES RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULTS. 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 24405191 ↗
• MalfunctionFeb 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 TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6220 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS HS TROPONIN I (HSTNI) RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. PATIENT 1 VITROS TROPI ES RESULT OF 0.067 NG/ML (ABOVE THE UPPER REFERENCE INTERVAL) VERSUS THE EXPECTED VITROS HSTNI RESULT OF <1.5 NG/L (BELOW THE ACUTE MYOCARDIAL INFARCTION CUTOFF OF 11 NG/L) 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 TROPI ES RESULT OF 0.067 NG/ML WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380937 ↗
• MalfunctionFeb 17, 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 TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS TROPI ES LOT: 6220 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF 0.183 NG/ML VERSUS THE EXPECTED RESULT OF 0.025 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 TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369681 ↗
• MalfunctionFeb 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6110 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS HS TROPONIN I (HSTNI) RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. PATIENT 1 VITROS TROPI ES RESULT OF 0.107 NG/ML (ABOVE THE UPPER REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF <1.5 NG/L. A VITROS HSTNI RESULT OF <1.5 NG/L (BELOW THE CUTOFF FOR DETERMINATION OF ACUTE MYOCARDIAL INFARCTION) CUTOFF 11 NG/L. 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 TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. A PHYSICIAN QUESTIONED THE RESULT, AND NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT OF <1.5 NG/L (VITROS HSTNI) WAS LATER ISSUED FOR THE PATIENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278461 ↗
• MalfunctionFeb 4, 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 TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF 0.059 NG/ML VS. THE EXPECTED RESULT OF <0.020 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 TROPI ES RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY, AND 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 613240.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258753 ↗
• MalfunctionFeb 3, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6110 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO THE RESULTS FOR THE SAMPLE OBTAINED USING THE VITROS HS TROPONIN I (HSTNI) ASSAY AS WELL AS FROM A NON-VITROS ROCHE METHOD. PATIENT SAMPLE RESULT OF 0.067 NG/ML (ABOVE THE UPPER REFERENCE INTERVAL) VS. A VITROS HSTNI RESULT OF <1.5 NG/L (BELOW THE CUTOFF FOR DETERMINATION OF ACUTE MYOCARDIAL INFARCTION) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS REPORTED FROM THE LABORATORY. HOWEVER, THE RESULT WAS QUESTIONED BY THE PHYSICIAN AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. 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 400300343 AND R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244510 ↗
• MalfunctionJan 28, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED USING TWO DIFFERENT LOTS OF VITROS TROPI ES REAGENT LOTS ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROES TROPI ES REAGENT LOT 6230: PATIENT 1 SAMPLE RESULT OF 0.073 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2 SAMPLE RESULT OF 0.071 NG/ML VERSUS THE EXPECTED RESULT OF 0.014 NG/ML VITROES TROPI ES REAGENT LOT 6280: PATIENT 7 SAMPLE RESULT OF 0.059 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 8 SAMPLE RESULT OF 0.066 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT REMAINS UNKNOWN IF THE HIGHER-THAN-EXPECTED VITROS TROPI ES RESULTS WERE REPORTED FROM THE LABORATORY AND/OR IF CORRECTED REPORTS WERE ISSUED. HOWEVER, THE CUSTOMER CONFIRMED THAT NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE AFFECTED TROPI ES RESULTS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199793 ↗
• MalfunctionJan 27, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED USING TWO DIFFERENT LOTS OF VITROS TROPI ES REAGENT LOTS ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROES TROPI ES REAGENT LOT 6230: PATIENT 1 SAMPLE RESULT OF 0.073 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2 SAMPLE RESULT OF 0.071 NG/ML VERSUS THE EXPECTED RESULT OF 0.014 NG/ML VITROES TROPI ES REAGENT LOT 6280: PATIENT 7 SAMPLE RESULT OF 0.059 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 8 SAMPLE RESULT OF 0.066 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT REMAINS UNKNOWN IF THE HIGHER-THAN-EXPECTED VITROS TROPI ES RESULTS WERE REPORTED FROM THE LABORATORY AND/OR IF CORRECTED REPORTS WERE ISSUED. HOWEVER, THE CUSTOMER CONFIRMED THAT NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE AFFECTED TROPI ES RESULTS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191306 ↗
• MalfunctionJan 12, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPONIN I ES (TROPI ES) RESULTS WERE OBTAINED FROM FOUR PATIENT SAMPLES FROM FOUR DIFFERENT PATIENTS WHEN TESTED USING VITROS TROPI ES LOT: 6110 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF 0.067 NG/ML (>URL) VERSUS THE EXPECTED RESULT OF <0.012 NG/ML (<AMI) PATIENT 2 RESULT OF 0.648 NG/ML (>AMI) VERSUS THE EXPECTED RESULT OF <0.012 NG/ML (<AMI) PATIENT 3 RESULT OF 0.418 NG/ML (>AMI) VERSUS THE EXPECTED RESULT OF <0.012 NG/ML (<AMI) PATIENT 4 RESULT OF 0.222 NG/ML (>AMI) VERSUS THE EXPECTED RESULT OF <0.012 NG/ML (<AMI) 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 TROPI ES RESULTS WERE 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046676 ↗
• MalfunctionJan 9, 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 TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS NON-REPRODUCIBLE, HIGHER THAN EXPECTED WHEN COMPARED TO THE REPEAT VITROS TROPI ES RESULT OBSERVED FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE 1 RESULT OF 0.733 NG/ML (ABOVE THE AMI CUTOFF) VERSUS THE REPEAT RESULT OF < 0.012 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 TROPI ES RESULT WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. A CORRECTED REPORT WAS LATER ISSUED FOR THE AFFECTED SAMPLE. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE INITIAL REPORTED TROPI ES RESULT AND 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 613066.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026829 ↗
• MalfunctionDec 22, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED TROPONIN ES RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6070 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS HS TROPONIN I (HSTNI) RESULT AND A NON-VITROS TROPONIN RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. PATIENT 1, SAMPLE 1 VITROS TROPI ES RESULTS OF 0.256 AND 0.26 NG/ML WHICH IS > AMI CUTOFF 0.120 NG/ML VERSUS THE EXPECTED RESULT HSTNI RESULT OF <AMI NEGATIVE (<1.5 NG/L) WHICH IS < AMI CUTOFF 11 NG/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 TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. 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 23863423 ↗