VITROS 6177333Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10758750035052), received between Nov 8, 2024 and Sep 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899060 ↗
• MalfunctionSep 25, 2026False Negative Result

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report false-negative Syphilis (SYPH) results obtained from samples from two different patients using VITROS Immunodiagnostics Product Syphilis TPA Reagent, lot 1860, on two different VITROS 3600 Immunodiagnostic Systems. The non-reactive VITROS results were considered discordant when compared to non-VITROS DiaSorin method reactive results obtained for the same patient samples. Additional confirmatory testing was performed using a non-VITROS Immunoblot recomLine Treponema IgG/IgM method where both patient samples produced reactive results, supporting the results obtained by the alternative testing method. Patient 1, VITROS SYPH reagent lot 1860 result of 0.557 s/c on Instrument J36001395 vs. the expected non-VITROS interpretation of reactive. Patient 2, VITROS SYPH reagent lot 1860 result of 0.633 s/c on instrument J36001016 vs. the expected non-VITROS interpretation of reactive. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The discordant, non-reactive VITROS Syph results were not reported from the labo

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899038 ↗
• MalfunctionMay 19, 2026False Positive Result

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT A DISCORDANT, REACTIVE VITROS SYPH RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS SYPH TPA REAGENT LOT 1850 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO THE RESULT FROM THE SAME SAMPLE WHEN TESTED USING AN ALTERNATE NON-VITROS ABBOTT CHEMILUMINESCENCE METHOD. PATIENT 1 SAMPLE RESULTS OF 1.50 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF 0.21 (NEGATIVE) (ABBOTT) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, FALSE REACTIVE VITROS SYPH RESULT WAS NOT REPORTED FROM THE LABORATORY. 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 (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220112 ↗
• MalfunctionApr 20, 2026False Positive Result

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTRE (TSC) ON BEHALF OF THE CUSTOMER TO REPORT DISCORDANT, REACTIVE SYPHILIS (SYPH) RESULTS OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS WHEN TESTED USING A VITROS IMMUNODIAGNOSTICS PRODUCT SYPHILIS TPA REAGENT, LOT 1820 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO NON-REACTIVE RESULTS OBTAINED FROM A NON-VITROS RAPID PLASMA REAGIN (RPR) METHOD AND A NON-VITROS ABBOTT ALINITY METHOD FROM THE SAME PATIENT SAMPLES. PATIENT 1, SYPH RESULTS OF 1.836 AND 1.825 S/C (REACTIVE) VS. THE EXPECTED NON-VITROS ABBOTT ALINITY RESULT OF 0.07 S/C (NON-REACTIVE). PATIENT 2, SYPH RESULT OF 1.940 S/C (REACTIVE) VS. THE EXPECTED NON-VITROS ABBOTT ALINITY RESULT OF 0.05 S/C (NON-REACTIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, REACTIVE VITROS SYPH RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS BEING S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926917 ↗
• MalfunctionApr 20, 2026False Positive Result

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTRE (TSC) ON BEHALF OF THE CUSTOMER TO REPORT DISCORDANT, REACTIVE SYPHILIS (SYPH) RESULTS OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS WHEN TESTED USING A VITROS IMMUNODIAGNOSTICS PRODUCT SYPHILIS TPA REAGENT, LOT 1820 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO NON-REACTIVE RESULTS OBTAINED FROM A NON-VITROS RAPID PLASMA REAGIN (RPR) METHOD AND A NON-VITROS ABBOTT ALINITY METHOD FROM THE SAME PATIENT SAMPLES. PATIENT 1, SYPH RESULTS OF 1.836 AND 1.825 S/C (REACTIVE) VS. THE EXPECTED NON-VITROS ABBOTT ALINITY RESULT OF 0.07 S/C (NON-REACTIVE). PATIENT 2, SYPH RESULT OF 1.940 S/C (REACTIVE) VS. THE EXPECTED NON-VITROS ABBOTT ALINITY RESULT OF 0.05 S/C (NON-REACTIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, REACTIVE VITROS SYPH RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS BEING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926904 ↗
• MalfunctionJan 30, 2026False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT VITROS SYPHILIS (SYPH) REACTIVE RESULTS WERE OBTAINED FROM THREE PATIENT SAMPLES USING TWO DIFFERENT VITROS SYPH REAGENT LOTS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE VITROS SYPH REACTIVE RESULTS WERE DISCORDANT WHEN COMPARED TO NEGATIVE RESULTS OBTAINED FROM NON-VITROS SYPHILIS METHODS. THE RESULTS WERE OBTAINED USING VITROS SYPH REAGENT LOTS 1760 AND 1770. VITROS SYPH REAGENT LOT 1760 PATIENT SAMPLE 1 VITROS SYPH RESULT OF 3.305 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE VITROS SYPH REAGENT LOT 1770 PATIENT SAMPLE 4 VITROS SYPH RESULT OF 3.204 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE PATIENT SAMPLE 5 VITROS SYPH RESULT OF 1.302 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE THE DISCORDANT REACTIVE VITROS SYPHILIS RESULTS HAD NOT BEEN REPORTED TO A PHYSICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM MADE AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225953 ↗
• MalfunctionJan 30, 2026False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT VITROS SYPHILIS (SYPH) REACTIVE RESULTS WERE OBTAINED FROM THREE PATIENT SAMPLES USING TWO DIFFERENT VITROS SYPH REAGENT LOTS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE VITROS SYPH REACTIVE RESULTS WERE DISCORDANT WHEN COMPARED TO NEGATIVE RESULTS OBTAINED FROM NON-VITROS SYPHILIS METHODS. THE RESULTS WERE OBTAINED USING VITROS SYPH REAGENT LOTS 1760 AND 1770. VITROS SYPH REAGENT LOT 1760 PATIENT SAMPLE 1 VITROS SYPH RESULT OF 3.305 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE VITROS SYPH REAGENT LOT 1770 PATIENT SAMPLE 4 VITROS SYPH RESULT OF 3.204 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE PATIENT SAMPLE 5 VITROS SYPH RESULT OF 1.302 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE THE DISCORDANT REACTIVE VITROS SYPHILIS RESULTS HAD NOT BEEN REPORTED TO A PHYSICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM MADE AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225833 ↗
• MalfunctionJan 30, 2026False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT VITROS SYPHILIS (SYPH) REACTIVE RESULTS WERE OBTAINED FROM THREE PATIENT SAMPLES USING TWO DIFFERENT VITROS SYPH REAGENT LOTS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE VITROS SYPH REACTIVE RESULTS WERE DISCORDANT WHEN COMPARED TO NEGATIVE RESULTS OBTAINED FROM NON-VITROS SYPHILIS METHODS. THE RESULTS WERE OBTAINED USING VITROS SYPH REAGENT LOTS 1760 AND 1770. VITROS SYPH REAGENT LOT 1760: PATIENT SAMPLE 1 VITROS SYPH RESULT OF 3.305 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE VITROS SYPH REAGENT LOT 1770: PATIENT SAMPLE 4 VITROS SYPH RESULT OF 3.204 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE PATIENT SAMPLE 5 VITROS SYPH RESULT OF 1.302 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE THE DISCORDANT REACTIVE VITROS SYPHILIS RESULTS HAD NOT BEEN REPORTED TO A PHYSICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM MADE AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225825 ↗
• MalfunctionJun 4, 2025False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT DISCORDANT, REACTIVE SYPHILIS (SYPH2) RESULTS WERE OBTAINED WHEN TWO SAMPLES FROM THE SAME PATIENT WERE TESTED USING VITROS SYPH2 LOT: 0020 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS FOR THE PATIENT WERE DISCORDANT WHEN COMPARED TO NON-VITROS SYPH RESULTS FOR THE PATIENT. PATIENT 1, RESULTS OF 1.74 AND 2.47 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NEGATIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, REACTIVE VITROS SYPH2 RESULTS FOR THE PATIENT WERE NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140646 ↗
• MalfunctionJun 4, 2025False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT DISCORDANT, REACTIVE SYPHILIS (SYPH2) RESULTS WERE OBTAINED WHEN TWO SAMPLES FROM THE SAME PATIENT WERE TESTED USING VITROS SYPH2 LOT 0020 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS FOR THE PATIENT WERE DISCORDANT WHEN COMPARED TO NON-VITROS SYPH RESULTS FOR THE PATIENT. PATIENT 1, RESULTS OF 1.74 AND 2.47 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NEGATIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, REACTIVE VITROS SYPH2 RESULTS FOR THE PATIENT WERE NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. 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 22140612 ↗
• MalfunctionDec 4, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE REACTIVE SYPH2 RESULTS WERE OBTAINED WHEN TWO DIFFERENT SAMPLES WERE TESTED USING VITROS SYPH2 LOT 0010 ACROSS TWO VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS FOR THE SAMPLES WERE DISCORDANT WHEN COMPARED TO NON-VITROS SYPH RESULTS FOR THE SAMPLES. SAMPLE SD161 RESULT OF 2.30 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NON-REACTIVE SAMPLE SA242 RESULT OF 2.71 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NON-REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, REACTIVE VITROS SYPH2 RESULTS FOR THE SAMPLES WERE OBTAINED AS PART OF INTERNAL TESTING CONDUCTED AT ORTHO ROCHESTER AND WERE NOT REPORTED FROM LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) NONCONFORMANCE (B)(4) AND REPORTABILITY ASSESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846875 ↗
• MalfunctionDec 4, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE REACTIVE SYPH2 RESULTS WERE OBTAINED WHEN TWO DIFFERENT SAMPLES WERE TESTED USING VITROS SYPH2 LOT 0010 ACROSS TWO VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS FOR THE SAMPLES WERE DISCORDANT WHEN COMPARED TO NON-VITROS SYPH RESULTS FOR THE SAMPLES. SAMPLE SD161 RESULT OF 2.30 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NON-REACTIVE SAMPLE SA242 RESULT OF 2.71 S/C (REACTIVE) VERSUS THE NON-VITROS SYPH RESULTS OF NON-REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, REACTIVE VITROS SYPH2 RESULTS FOR THE SAMPLES WERE OBTAINED AS PART OF INTERNAL TESTING CONDUCTED AT ORTHO ROCHESTER AND WERE NOT REPORTED FROM LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) NONCONFORMANCE (B)(4) AND REPORTABILITY ASSESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846465 ↗
• MalfunctionNov 8, 2024False Positive Result; False Positive Result

  AN INTERNAL ORTHO CLINICAL DIAGNOSTICS INVESTIGATION REPORTED DISCORDANT, FALSE REACTIVE SYPHILIS 2 (SYPH2) RESULTS WERE OBTAINED WHEN A SINGLE IVDD NEGATIVE PANEL SAMPLE WAS TESTED USING VITROS SYPH2 LOT 0010 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. N103 SAMPLE RESULTS OF 1.71, 1.14, 4.49, 1.29, 1.00, 1.82, 1.59, 4.36, 4.61 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NON-REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, REACTIVE VITROS SYPH2 RESULTS FOR SAMPLE N103 WERE OBTAINED AS PART OF TROUBLESHOOTING INVESTIGATIONS CONDUCTED AT ORTHO ROCHESTER AND WERE NOT REPORTED FROM LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) NONCONFORMANCE (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643631 ↗