VITROS 6801812Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750001415), received between Mar 22, 2023 and Oct 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, REACTIVE ANTI-HAV IGM (AHAVM) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS AHAVM LOT 5810 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS AHAVM RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS AHAVT RESULTS FROM THE SAME PATIENT SAMPLE. PATIENT 1, VITROS AHAVM RESULTS OF 1.56 AND 1.61 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NON-REACTIVE (<0.80 S/C) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, REACTIVE VITROS AHAVM RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULT. 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 17969544 ↗
• MalfunctionJun 13, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, REACTIVE ANTI-HAV IGM (AHAVM) RESULTS WERE OBTAINED FROM TWO SAMPLES FROM THE SAME PATIENT WHEN TESTED USING VITROS AHAVM LOT 5750 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS AHAVM RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS AHAVT RESULTS FROM THE SAME PATIENT SAMPLES AND A HEPATITIS A RNA RESULT FOR THE PATIENT WHICH DID NOT SUGGEST ACUTE HEPATITIS A INFECTION. PATIENT 1, SAMPLE 1, VITROS AHAVM RESULTS OF 7.93, 7.87 AND 7.77 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NON-REACTIVE PATIENT 1, SAMPLE 2, VITROS AHAVM RESULTS OF 4.23 AND 4.53 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. THE DISCORDANT, REACTIVE VITROS AHAVM 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115536 ↗
• MalfunctionJun 13, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, REACTIVE ANTI-HAV IGM (AHAVM) RESULTS WERE OBTAINED FROM TWO SAMPLES FROM THE SAME PATIENT WHEN TESTED USING VITROS AHAVM LOT 5750 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS AHAVM RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS AHAVT RESULTS FROM THE SAME PATIENT SAMPLES AND A HEPATITIS A RNA RESULT FOR THE PATIENT WHICH DID NOT SUGGEST ACUTE HEPATITIS A INFECTION. PATIENT 1, SAMPLE 1, VITROS AHAVM RESULTS OF 7.93, 7.87 AND 7.77 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NON-REACTIVE PATIENT 1, SAMPLE 2, VITROS AHAVM RESULTS OF 4.23 AND 4.53 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. THE DISCORDANT, REACTIVE VITROS AHAVM 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 MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115524 ↗
• MalfunctionMar 22, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE VITROS ANTI-HBC IGM (AHBCM) AND ANTI-HAV IGM (AHAVM) RESULTS OBTAINED FROM TWO SAMPLES COLLECTED FROM THE SAME PATIENT COMPARED TO ANTI-HBC TOTAL AND ANTI-HAV TOTAL NEGATIVE RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLES WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. SAMPLE 1 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 1 VITROS AHBCM RESULT OF 2.87 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHBCM RESULT OF 2.91 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS AHBCM AND AHAVM REACTIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY BASED ON THE CONCORDANT RESULTS OBTAINED AT THE (B)(6) CLINIC. THERE WAS NO REPORTED ALLEGATION OF 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591930 ↗