VITROS 6801428Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10758750001217), received between Jan 4, 2023 and Aug 7, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174146 ↗
• MalfunctionAug 7, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173294 ↗
• MalfunctionJul 8, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750059 ↗
• MalfunctionApr 10, 2026False Positive Result; Non Reproducible Results

  A FIELD APPLICATION SPECIALIST (FAS), ON BEHALF OF A CUSTOMER, CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A DISCORDANT, REACTIVE (POSITIVE) VITROS AHBC RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC (AHBC) REAGENT PACK LOT 2910 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE REPEAT RESULT OBTAINED FROM THE SAME SAMPLE. PATIENT SAMPLE RESULT OF 0.1 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF 3.2 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 AHBC 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 614102.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844146 ↗
• MalfunctionMar 30, 2026False Positive Result; Incorrect Measurement

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE ANTI-HBC (AHBC) RESULTS OBTAINED WHEN TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WERE TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC (AHBC) REAGENT PACK LOT 2910, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE RESULT OBTAINED FROM A NON-VITROS ABBOTT ALINITY METHOD. PATIENT 1, SAMPLE 1 VITROS AHBC RESULT OF 0.84 S/C (REACTIVE) VS THE NON-VITROS AHBC RESULT OF 0.47 S/C (NON-REACTIVE). PATIENT 1, SAMPLE 2 VITROS AHBC RESULT OF 0.56 S/C (REACTIVE) VS THE NON-VITROS AHBC RESULT OF 0.47 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, FALSE REACTIVE VITROS AHBC RESULTS 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 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713027 ↗
• MalfunctionMar 30, 2026False Positive Result; Incorrect Measurement

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE ANTI-HBC (AHBC) RESULTS OBTAINED WHEN TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WERE TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC (AHBC) REAGENT PACK LOT: 2910, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE RESULT OBTAINED FROM A NON-VITROS ABBOTT ALINITY METHOD. PATIENT 1, SAMPLE 1 VITROS AHBC RESULT OF 0.84 S/C (REACTIVE) VS THE NON-VITROS AHBC RESULT OF 0.47 S/C (NON-REACTIVE). PATIENT 1, SAMPLE 2 VITROS AHBC RESULT OF 0.56 S/C (REACTIVE) VS THE NON-VITROS AHBC RESULT OF 0.47 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, FALSE REACTIVE VITROS AHBC RESULTS 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 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712999 ↗
• MalfunctionNov 19, 2025False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, FALSE NEGATIVE ANTI-HBC (AHBC) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS AHBC LOT 2870 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A REACTIVE RESULT OBTAINED FROM AN UNKNOWN NON-VITROS ANTI-HBS METHOD AND A REACTIVE VITROS AHBC RESULT. PATIENT 1, SAMPLE 2 VITROS AHBC RESULT OF 2.62 S/C (NON-REACTIVE) VS THE VITROS AHBC RESULT OF 0.17 S/C (REACTIVE). 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 AHBC RESULT 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594376 ↗
• MalfunctionApr 25, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A FALSE NEGATIVE ANTI-HBC (AHBC) RESULT WAS OBTAINED WHEN A VITROS AHBC LEVEL 2 REACTIVE CONTROL (LOT 1240) WAS TESTED USING VITROS AHBC REAGENT LOT 2780 ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS AHBC RESULT OF 1.22 S/C (NEGATIVE) 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 ON PATIENT SAMPLES. THE FALSE NEGATIVE VITROS AHBC RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID AND WAS 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 19179975 ↗
• MalfunctionJan 10, 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-HBC (AHBC) RESULT FROM A SINGLE PATIENT SAMPLE WAS OBTAINED WHEN TESTED USING VITROS AHBC LOT 2710 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS ABBOTT RESULT. VITROS AHBC RESULT OF 1.93 S/C (NON-REACTIVE) VS. THE EXPECTED RESULT OF POSITIVE. 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 AHBC RESULT 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)(6) AND REPORTABILITY ASSESSMENT 604644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486984 ↗
• MalfunctionSep 28, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, REACTIVE ANTI-HBC (AHBC) RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS AHBC LOT 2730 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE NON-VITROS ROCHE RESULT FOR THE SAME PATIENT SAMPLE. PATIENT 1, VITROS AHBC RESULTS OF 0.58, 0.56 AND 0.51 S/C (REACTIVE) VERSUS THE ROCHE RESULT 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 AHBC RESULTS 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 17831885 ↗
• MalfunctionJan 4, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE VITROS ANTI-HBC (AHBC) RESULTS AND DISCORDANT, POSITIVE VITROS ANTI-HBS (AHBS) SAMPLES FROM ONE PATIENT WERE TESTED USING VITROS AHBC LOT 2680 AND VITROS AHBS LOT 3990 ON A VITROS 5600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO RESULTS FROM A NON-VITROS (ABBOTT) METHOD. PATIENT 1, VITROS AHBS RESULTS OF 40.76 AND 48.27 MIU/L (POSITIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE PATIENT 1, VITROS AHBC RESULT OF 1.98 AND 1.87 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE THE DISCORDANT VITROS AHBC AND VITROS AHBS RESULTS 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097139 ↗