VITROS 6197735Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750033287), received between Aug 25, 2023 and Mar 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025High 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 PROCALCITONIN (PCT) RESULT WAS OBTAINED FROM A SAMPLE FROM A SINGLE PATIENT WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM USING REAGENT LOT 0440 WHEN COMPARED TO A REPEAT PCT TEST RESULT OBTAINED FROM A REPEAT TEST OF THE SAME SAMPLE ON THE SAME VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 1.916 NG/ML VERSUS THE EXPECTED (REPORTED) REPEAT RESULT OF 0.059 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 PCT RESULT OF 1.916 NG/ML WAS QUESTIONED BY THE LABORATORY STAFF AND REPEAT TEST EVENTS WERE SUBSEQUENTLY PROCESSED. THE QUESTIONED RESULT WAS NOT REPORTED FROM THE LABORATORY AND 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 21559949 ↗
• MalfunctionDec 22, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS B¿R¿A¿H¿M¿S PROCALCITONIN (PCT) QC FLUID RESULTS WERE OBTAINED FROM VITROS B¿R¿A¿H¿M¿S PCT LOT 0360 LEVEL 2 QUALITY CONTROL (QC) FLUID, USING VITROS IMMUNODIAGNOSTIC PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT ON A VITROS 5600 INTEGRATED SYSTEM VITROS B¿R¿A¿H¿M¿S PCT LEVEL 2 RESULTS OF 0.03 AND 0.03 NG/ML VERSUS THE EXPECTED RESULT OF 1.91 NG/ML 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¿R¿A¿H¿M¿S PCT RESULTS WERE FROM NON-PATIENT FLUID. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED AND THERE IS 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 18382573 ↗
• MalfunctionAug 25, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IMMUNODIAGNOSTICS PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT PACK (PCT) RESULTS WERE OBTAINED FROM 10 DIFFERENT PATIENT SAMPLES AND 2 DIFFERENT LEVELS OF VITROS PCT LOT 0320 CONTROLS TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 8.76 NG/ML PATIENT SAMPLE 2 VITROS PCT RESULT OF 0.226 NG/ML VS. THE EXPECTED RESULT OF 2.25 NG/ML PATIENT SAMPLE 3 VITROS PCT RESULT OF 0.062 NG/ML VS. THE EXPECTED RESULT OF 9.28 NG/ML PATIENT SAMPLE 5 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 5.59 NG/ML PATIENT SAMPLE 6 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 1.22 NG/ML PATIENT SAMPLE 7 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 3.14 NG/ML PATIENT SAMPLE 9 VITROS PCT RESULT OF 0.037 NG/ML VS. THE EXPECTED RESULT OF 4.31 NG/ML PATIENT SAMPLE 12 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 3.77 NG/ML PATIENT SAMPLE 13 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 12.8 NG/ML PATIENT SAMPLE 14 VITROS PCT RESULT OF 0.100 NG/M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627054 ↗