VITROS 6801325Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10758750001095), received between Jan 10, 2023 and Sep 10, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715478 ↗
• MalfunctionOct 30, 2025False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE (NEGATIVE) VITROS AHCV RESULTS WERE OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS AHCV REAGENT LOTS 5840, 5900 AND 5921 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE RESULTS OBTAINED USING A NON-VITROS ELISA (VECTOR-BEST) METHOD OBTAINED FROM THE SAME SAMPLES. PATIENT 2 RESULTS OF 0.54 AND 0.80 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REACTIVE VITROS AHCV RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULTS. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424097 ↗
• MalfunctionJul 11, 2025False Negative Result; Low Test Results; False Negative Result; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT DISCORDANT NEGATIVE VITROS HIV COMBO (HIVC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS ANTI-HIV 1+2 LOT 1160 CONTROLS AND DISCORDANT NEGATIVE VITROS HEPATITIS C VIRUS (HCV) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS ANTI-HCV LOT 1580 CONTROL. THE RESULTS WERE OBTAINED WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS ANTI-HIV 1+2 LOT 1160 L2 CONTROL VITROS HIVC RESULTS OF 0.22, 0.23, 0.24 AND 0.18 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). VITROS ANTI-HIV 1+2 LOT 1160 L3 CONTROL VITROS HIVC RESULT OF 0.13 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). VITROS ANTI-HCV LOT 1580 REACTIVE CONTROL VITROS AHCV REAGENT LOT 5810 RESULTS OF 0.080, 0.060, 0.049, 0.025, 0.009 AND 0.018 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS ARE BEING SUBMITTED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479719 ↗
• MalfunctionSep 17, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NON-REACTIVE RESULTS WERE OBTAINED WHEN A LEVEL 2 (REACTIVE) VITROS AHCV CONTROL (LOT 1520) WAS PROCESSED USING VITROS AHCV LOT 0985 ACROSS TWO VITROS XT7600 INTEGRATED SYSTEMS. VITROS XT7600 INTEGRATED SYSTEM ((B)(6) - J1) LEVEL 2 (REACTIVE) CONTROL RESULTS OF 0.64, 0.61, 0.63, 0.62, 0.82, 0.81, 0.73, 0.69, 0.67 AND 0.67 S/C (NON- REACTIVE) VERSUS THE EXPECTED RESULTS OF REACTIVE (?1.00 S/C) VITROS XT7600 INTEGRATED SYSTEM ((B)(6) - J2) LEVEL 2 (REACTIVE) CONTROL RESULTS OF 0.62, 0.59, 0.57, 0.54, 0.53, 0.49, 0.48, 0.47, 0.47 AND 0.47 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULTS OF REACTIVE (?1.00 S/C) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE NON-REACTIVE VITROS AHCV RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN 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 CORR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240813 ↗
• MalfunctionSep 17, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NON-REACTIVE RESULTS WERE OBTAINED WHEN A LEVEL 2 (REACTIVE) VITROS AHCV CONTROL (LOT 1520) WAS PROCESSED USING VITROS AHCV LOT 0985 ACROSS TWO VITROS XT7600 INTEGRATED SYSTEMS. VITROS XT7600 INTEGRATED SYSTEM (76000992 - J1) LEVEL 2 (REACTIVE) CONTROL RESULTS OF 0.64, 0.61, 0.63, 0.62, 0.82, 0.81, 0.73, 0.69, 0.67 AND 0.67 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULTS OF REACTIVE (?1.00 S/C) VITROS XT7600 INTEGRATED SYSTEM (76000994 - J2) LEVEL 2 (REACTIVE) CONTROL RESULTS OF 0.62, 0.59, 0.57, 0.54, 0.53, 0.49, 0.48, 0.47, 0.47 AND 0.47 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULTS OF REACTIVE (?1.00 S/C) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE NON-REACTIVE VITROS AHCV RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN 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 C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240510 ↗
• MalfunctionSep 3, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT FALSE NEGATIVE ANTI-HCV RESULTS WERE OBTAINED FROM A SINGLE DONOR SAMPLE WHEN USING VITROS ANTI-HCV REAGENT LOT 5640 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TESTING ON THE DONOR SAMPLE. DONOR SAMPLE RESULTS OF 0.54, 0.53, 0.67 AND 0.57 S/C (NEGATIVE) VS EXPECTED RESULT OF REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT NEGATIVE VITROS ANTI-HCV RESULTS WERE 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 20126325 ↗
• MalfunctionAug 7, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT NEGATIVE ANTI-HCV RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WHEN USING VITROS ANTI-HCV REAGENT LOT 5610 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO POSITIVE HCV RESULTS OBTAINED ON FOUR NON-VITROS METHODS (ELISA, VIDAS ELFA, CLIA AND WESTERN BLOT). VITROS ECI (S/N (B)(6) RESULTS: PATIENT 1, SAMPLE 1 RESULT OF 0.40 S/C (NEGATIVE) VS EXPECTED RESULT REACTIVE PATIENT 1, SAMPLE 2 RESULT OF 0.40 S/C (NEGATIVE) VS EXPECTED RESULT REACTIVE VITROS 5600 (S/N (B)(6) RESULT: PATIENT 1, SAMPLE 2 RESULT OF 0.31 S/C (NEGATIVE) VS EXPECTED RESULT REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT NEGATIVE VITROS ANTI-HCV RESULTS WERE 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 19932419 ↗
• MalfunctionApr 24, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT NON-REACTIVE VITROS ANTI-HCV RESULT FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING A VITROS ANTI-HCV REAGENT LOT 5551 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO POSITIVE RESULTS OBTAINED FROM A NON-VITROS RECOMBINANT IMMUNOBLOT ASSAY (RIBA) METHOD AND REPEAT TESTING ON THE VITROS SYSTEM. PATIENT 1 VITROS ANTI-HCV RESULT OF 0.80 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REACTIVE VITROS ANTI-HCV RESULT WAS 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) AND REPORTABILITY ASSESSMENT (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173281 ↗
• MalfunctionJan 10, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE AHCV RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS AHCV LOT 5280 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO REACTIVE/POSITIVE NON-VITROS METHOD RESULTS FOR THE SAME PATIENT SAMPLE. PATIENT 1, VITROS AHCV RESULTS OF 0.12 AND 0.04 S/C (NON-REACTIVE) VERSUS EXPECTED RESULTS 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 AHCV RESULTS FOR THE PATIENT 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 IS NUMBER TWO OF TWO MDR¿S 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600466.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129398 ↗
• MalfunctionJan 10, 2023False Negative Result; False Negative Result

  HOLD FOR CS 01/13/2023A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE AHCV RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS AHCV LOT 5280 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO REACTIVE/POSITIVE NON-VITROS METHOD RESULTS FOR THE SAME PATIENT SAMPLE. PATIENT 1, VITROS AHCV RESULTS OF 0.12 AND 0.04 S/C (NON-REACTIVE) VERSUS EXPECTED RESULTS 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 AHCV RESULTS FOR THE PATIENT 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 IS NUMBER ONE OF TWO MDR¿S 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600466.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129390 ↗