VITROS 6912232Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10758750033522), received between Mar 25, 2026 and May 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED VITROS HS TROPONIN I (HSTNI) RESULT WAS OBTAINED FROM A SAMPLE PROCESSED DURING A CORRELATION STUDY USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I REAGENT LOT 0050 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT AND HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULT FROM THE SAME SAMPLE USING THE VITROS TROPI ES METHOD. SAMPLE M33M VITROS HSTNI RESULT OF 275.2 NG/L (ABOVE THE MALE 99TH PERCENTILE URL OF 20.40 NG/L) VS THE VITROS TROPI ES METHOD RESULT OF <0.012 NG/ML (BELOW THE UPPER REFERENCE INTERVAL (URL) OF 0.034 NG/ML) 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 HSTNI RESULT WAS OBTAINED DURING A CORRELATION STUDY AND 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 25206400 ↗
• MalfunctionMay 15, 2026High Test Results

  A FIELD APPLICATION SPECIALIST (FAS), ON BEHALF OF A CUSTOMER, CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED VITROS HSTNI RESULTS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A CORRELATION STUDY USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I REAGENT LOT 0021 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT AND HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS FROM THE SAME SAMPLES USING THE VITROS TROPI ES METHOD. SAMPLE M6 VITROS HSTNI RESULTS OF 63.09 AND 47.42 NG/L (ABOVE THE FEMALE 99TH PERCENTILE URL OF 15.30 NG/L) VS THE VITROS TROPI ES METHOD RESULT OF 0.027 NG/ML (BELOW THE UPPER REFERENCE INTERVAL (URL) OF 0.034 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 HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). THERE WAS NO ALLEGATION OF PATIENT HARM AS A R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183040 ↗
• MalfunctionMay 14, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT HIGHER THAN EXPECTED VITROS HSTNI RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK LOT: 1510 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS BECKMAN HIGHLY SENSITIVE TROPONIN I RESULT BELOW THE UPPER REFERENCE INTERVAL (URL). NEITHER THE BECKMAN RESULT OR URL WERE PROVIDED. PATIENT SAMPLE VITROS HSTNI RESULTS OF 550.0, 568.6 AND 513.1 NG/L VERSUS A BECKMAN HIGHLY SENSITIVE TROPONIN I RESULT BELOW THE UPPER REFERENCE INTERVAL (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 HSTNI 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 25176510 ↗
• MalfunctionApr 23, 2026High Test Results; Non Reproducible Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT DISCORDANT, HIGHER-THAN-EXPECTED TROPONIN I RESULTS OBTAINED WHEN PERFORMING A PATIENT CORRELATION WHEN TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0021 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO REPEAT RESULT OBTAINED WHEN TESTED USING VITROS TROPONIN I ES (TROPI ES) REAGENT (LOT 6345) FOR THE SAME PATIENT SAMPLES. PATIENT 3, VITROS HSTNI = 245.30 NG/L (>12 NG/L, 99TH PERCENTILE URL FOR MALES) VS. VITROS TROPI ES </= 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 HSTNI RESULT WAS NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971596 ↗
• MalfunctionApr 23, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED RESULT WHEN COMPARING A VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) RESULT OBTAINED FROM A PATIENT SAMPLE TO THE RESULT OBTAINED USING VITROS TROPONIN I REAGENT ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS HSTNI = 353.8 NG/L (>MALE 99TH PERCENTILE URL) VERSUS TROPI ES =0.020 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 HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). 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 24971533 ↗
• MalfunctionApr 23, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED RESULT WHEN COMPARING A VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) RESULT OBTAINED FROM A PATIENT SAMPLE TO THE RESULT OBTAINED USING VITROS TROPONIN I REAGENT ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS HSTNI = 278.1 NG/ML (>MALE 99TH PERCENTILE URL) VERSUS TROPI ES = 0.020 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 HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971467 ↗
• MalfunctionApr 21, 2026High Test Results; Low Test Results; Non Reproducible Results

  A QUIDEL ORTHO FIELD APPLICATION SPECIALIST (FAS) REPORTED DISCORDANT, HIGHER AND LOWER THAN EXPECTED RESULTS OBTAINED FROM THREE DIFFERENT PATIENT SAMPLES COLLECTED FROM THREE DIFFERENT PATIENTS WHEN COMPARING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) RESULTS TO RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES USING A NON-VITROS SIEMENS EXL HIGHLY SENSITIVE TROPONIN I (HS TROP I) METHOD. THE VITROS HSTNI US RESULTS WERE OBTAINED ON A VITROS XT7600 INTEGRATED SYSTEM. SAMPLE M3 HSTNI RESULT OF 185.2 NG/L (>MALE 99TH PERCENTILE URL) VERSUS THE SIEMENS HS TROP I RESULT OF 36.3 NG/L (<DECISION THRESHOLD) SAMPLE M31 HSTNI RESULT OF <2.25 NG/L (<FEMALE 99TH PERCENTILE URL) VERSUS SIEMENS HS TROP I RESULT OF 111.5 NG/L (>DECISION THRESHOLD) SAMPLE M43 HSTNI RESULT OF <2.25 NG/L (<FEMALE 99TH PERCENTILE URL) VERSUS SIEMENS HS TROP I RESULT OF 52.3 NG/L (>DECISION THRESHOLD) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER AND LOWER THAN EXPECTED VITROS HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941692 ↗
• MalfunctionApr 17, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0030 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE VITROS TROPONIN I ES (TROPI ES) METHOD RESULT FOR THE SAME SAMPLE. PATIENT F16 VITROS HSTNI RESULT OF 126.2 NG/L (>9 NG/L, UPPER REFERENCE LIMIT (URL) CUTOFF) VS. EXPECTED NEGATIVE RESULT OF < 0.012 NG/L (< 0.034 NG/L, VITROS TROPI ES URL CUTOFF). THE HIGHER THAN EXPECTED VITROS HSTNI 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 24913697 ↗
• MalfunctionApr 17, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT LOWER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0021 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE NON-VITROS SIEMENS METHOD RESULT FOR THE SAME SAMPLE. PATIENT (MALE) M16 VITROS HSTNI < 2.25 NG/L (<12 NG/L, UPPER REFERENCE LIMIT (URL) CUTOFF) VS. EXPECTED POSITIVE RESULT OF 144.7 NG/L ( > 76.0 NG/L, NON-VITROS SIEMENS METHOD URL CUTOFF) 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 HSTNI RESULT WAS NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WAS GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). THERE WERE 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 24912706 ↗
• MalfunctionApr 15, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULTS OBTAINED FROM A PATIENT SAMPLE WHEN PERFORMING A COMPARISON STUDY USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0030 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO VITROS TROPES I ES RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES. PATIENT 1 VITROS HSTNI RESULTS OF 42.40, 26.53 NG/L (>/= 12.00 NG/L 99TH PERCENTILE URL FOR MALES) VS. VITROS TROPI ES 0.020 NG/ML (<URL 0.034 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 HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). 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 24884880 ↗
• MalfunctionApr 13, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED RESULTS WHEN COMPARING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) RESULTS OBTAINED FROM A PATIENT SAMPLE TO RESULTS OBTAINED USING VITROS TROPONIN I REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. M00019 HSTNI = 213.3 NG/L (>MALE 99TH PERCENTILE URL) VERSUS TROPI ES =0.013 NG/ML (<URL) A CONSULTATION WITH QUIDELORTHO MEDICAL SAFETY OFFICER, THIS RESULT IS REPORTABLE INDICATED THE FOLLOWING: SAMPLE M00019: A SAMPLE FROM A MALE PATIENT DIAGNOSED WITH "CALC OF KIDNEY" HAD A VITROS HSTNI RESULT OF 213.3 NG/L COMPARED WITH A VITROS I ES RESULT OF 0.013 NG/ML. THE VITROS HSTNI IS EXCEEDS FIVE TIMES THE 99TH PERCENTILE URL, WHICH IS CONSIDERED A POSITIVE PREDICTIVE VALUE FOR ACUTE MYOCARDIAL INFARCTION (AMI) ACCORDING TO THE 2023 ESC GUIDELINE ON THE MANAGEMENT OF ACUTE CORONARY SYNDROME, WHILE THE TROPONIN I ES RESULT WAS NEGATIVE - RESULT IS AROUND THE DETECTABILITY LIMIT OF THE ASSAY. THE DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION REQUIRES INTERPRETATION OF TROPONIN RESULTS IN CONJUNCTION WITH THE PATIENT'S CLINICAL HISTORY (EVIDENCE OF ACUTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860504 ↗
• MalfunctionApr 3, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED VITROS HS TROPONIN I (HSTNI) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED DURING A CORRELATION STUDY USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I REAGENT LOT: 0021 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT AND HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULT FROM THE SAME SAMPLE USING THE VITROS TROPI ES METHOD. PATIENT SAMPLE VITROS HSTNI (US) RESULT OF 129.6 NG/L (ABOVE THE MALE 99TH PERCENTILE URL OF 20.40 NG/L) VS THE VITROS TROPI ES METHOD RESULT OF 0.028 NG/ML (BELOW THE UPPER REFERENCE INTERVAL (URL) OF 0.034 NG/ML) 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 HSTNI RESULT WAS OBTAINED DURING A CORRELATION STUDY AND 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781839 ↗
• MalfunctionApr 3, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED TROPONIN I RESULTS OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT LOT 0021 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO THE RESULTS FOR THE SAME SAMPLES WHEN TESTED USING A NON-VITROS ISTAT METHOD. PATIENT 1 VITROS HSTNI (US) RESULT OF 2.85 NG/L (BELOW THE AMI CUTOFF OF 11.00 NG/L) VS THE ISTAT METHOD RESULT OF 64.5 NG/L (ABOVE THE REFERENCE RANGE CUTOFF OF </=34 NG/L) PATIENT 2 VITROS HSTNI (US) RESULT OF 2.72 NG/L (BELOW THE AMI CUTOFF OF 11.00 NG/L) VS THE ISTAT METHOD RESULT OF 58.5 NG/L (ABOVE THE REFERENCE RANGE CUTOFF OF </=34 NG/L) 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 HSTNI RESULTS WERE 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 A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775665 ↗
• MalfunctionMar 25, 2026High Test Results; Non Reproducible Results

  AN ORTHO FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT A DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT LOT 1380 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS HSTNI RESULT OF 1.723 NG/L (ABOVE THE AMI CUTOFF) VS THE EXPECTED RESULT OF < 1.50 NG/L (BELOW AMI CUTOFF) 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 HSTNI RESULT 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 400306348 AND REPORTABILITY ASSESSMENT 613817.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687084 ↗