VITROS 1922814Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10758750000272), received between Mar 6, 2023 and Mar 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 20, 2019Terminated

   Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

   Z-1292-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN THREE LEVELS OF VITROS TTCS (LOT 0920) WERE TESTING USING VITROS TSH LOT 7420 ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. LEVEL 1 RESULTS OF 0.197, 0.237, 0.159 AND 0.153 MIU/L VERSUS THE PACKAGE INSERT MEAN RESULT OF 0.042 MIU/L LEVEL 2 RESULTS OF 3.18, 2.98, 3.01, 3.00 AND 3.03 MIU/L VERSUS THE PACKAGE INSERT MEAN RESULT OF 2.29 MIU/L LEVEL 3 RESULTS OF 26.7, 26.6, 27.1, 27.2, 27.1, 27.3, 27.6, 28.4, 26.9, 27.5, 27.4 AND 27.5 MIU/L VERSUS THE PACKAGE INSERT MEAN RESULT OF 20.6 MIU/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. 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 21641444 ↗
• MalfunctionSep 18, 2024High Test Results; Non Reproducible Results; High 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 ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 5610 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 VITROS TROPI ES RESULT OF 0.058 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML. PATIENT 2 VITROS TROPI ES RESULT OF 0.061 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 HIGHER-THAN-EXPECTED VITROS TROPI ES PATIENTS SAMPLE RESULTS WERE NOT REPORTED FROM THE LABORATORY. 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 20246521 ↗
• MalfunctionMar 12, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCREPANT RESULT WAS OBTAINED BETWEEN VITROS ECI Q SYSTEM AND LABORATORY INFORMATION SYSTEM (LIS). VITROS TESTO RESULT OF 15.3 NG/DL VS THE EXPECTED RESULT OF 441.405 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE ERRONEOUS RESULT OF 15.3 NG/DL WAS REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT OF 441.405 NG/DL 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 NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890650 ↗
• MalfunctionFeb 19, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM VITROS TTC LEVEL 1 AND LEVEL 2 CONTROL FLUIDS LOT 0880, WHEN COMPARED TO THE VITROS TTC PI MEAN FOR THE RESPECTIVE VITROS CONTROL FLUID WHEN USING VITROS TSH REAGENT LOT 7100 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. TTC LEVEL 2 LOT 0880 RESULT OF 1.29 MIU/L VS. THE EXPECTED RESULT OF 2.43 MIU/L TTC LEVEL 1 LOT 0880 RESULTS OF 0.022 AND 0.019 MIU/L VS. THE EXPECTED RESULT OF 0.069 MIU/L 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 TSH RESULTS WERE FROM NON-PATIENT FLUID AND 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 18734781 ↗
• MalfunctionFeb 15, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS B-HCG II RESULT WAS OBTAINED WHEN VITROS REPRODUCTIVE ENDOCRINE QUALITY CONTROL FLUIDS WERE TESTED USING VITROS B-HCG II LOT 3790 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS RE LEVEL 1 CONTROL LOT 0870 B-HCG LOT 3790 RESULT OF 4.68 VERSUS THE EXPECTED RESULT OF 10.39 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 B-HCG II RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. 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 18711919 ↗
• MalfunctionDec 21, 2023High Test Results; Non Reproducible Results; High 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 TROPI ES RESULT WAS OBTAINED FROM A VITROS BUFFER SOLUTION (SPECIALTY DILUENT 3) KNOWN TO BE TROPONIN FREE WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. SPECIALTY DILUENT 3 RESULT OF 0.059 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 WAS FROM NON-PATIENT FLUID AND WAS 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 604354.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371560 ↗
• MalfunctionOct 26, 2023High Test Results; Non Reproducible Results; High 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) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 RESULT OF 0.066 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2 RESULT OF 0.063 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 RESULTS WERE NOT REPORTED FROM THE LABORATORY 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016084 ↗
• MalfunctionAug 29, 2023High Test Results; Non Reproducible Results; High 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 ECIQ IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 RESULT OF 0.166 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 WAS REPORTED FROM THE LABORATORY. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULT AND A CORRECTED REPORT 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 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 17640779 ↗
• MalfunctionMar 15, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI-IMMUNE CONTROL, LOT 2302 TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. MAS LEVEL 1 CONTROL FLUID VITROS TSH RESULTS OF 0.079, 0.044, 0.075 AND 0.038 MIU/L VS. THE BASELINE MEAN VALUE OF 0.135 MIU/L. 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 SAMPLES AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601121.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548645 ↗
• MalfunctionMar 6, 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 B-HCG II (BHCG) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS IMMUNODIAGNOSTICS PRODUCTS BHCG REAGENT IN COMBINATION WITH A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 RESULT OF 1542 MIU/ML VERSUS EXPECTED RESULT OF < 2.39 MIU/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 BHCG RESULT WAS NOT REPORTED FROM THE LABORATORY 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484781 ↗