VITROS 6801861Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10758750001521), received between Aug 3, 2023 and May 7, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026False Negative Result

  A CUSTOMER CONTACTED (B)(6) TO REPORT DISCORDANT, NON-REACTIVE (NEGATIVE) VITROS ANTI-HIV (AHIV) RESULTS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT LOT 4450 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE RESULTS USING A NON-VITROS ABBOTT METHOD AND FROM AN UNKNOWN CONFIRMATORY TESTING METHOD OBTAINED FROM THE SAME SAMPLE. PATIENT SAMPLE VITROS RESULTS OF 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 AHIV RESULTS WERE 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112115 ↗
• MalfunctionNov 18, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE AHIV RESULTS WERE OBTAINED WHEN A SINGLE PROFICIENCY SAMPLE WAS TESTED USING VITROS ANTI-HIV 1 + 2 (AHIV) LOT 4370 ACROSS A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS PEER RESULTS FOR THE SAME PROFICIENCY SAMPLE AND A NON-VITROS ABBOTT RESULT FOR THE SAME PROFICIENCY SAMPLE. BIORAD EQAS (REFERENCE 12000815, LOT 330800) SAMPLE 8 RESULTS OF 0.19 AND 0.19 S/C (NEGATIVE) VERSUS AN 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 DISCORDANT, NEGATIVE VITROS AHIV RESULTS WERE FROM A NON-PATIENT FLUID AND WERE REPORTED TO THE PROFICIENCY PROVIDER. 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 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712416 ↗
• MalfunctionNov 18, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE AHIV RESULTS WERE OBTAINED WHEN A SINGLE PROFICIENCY SAMPLE WAS TESTED USING VITROS ANTI-HIV 1 + 2 (AHIV) LOT 4370 ACROSS A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS PEER RESULTS FOR THE SAME PROFICIENCY SAMPLE AND A NON-VITROS ABBOTT RESULT FOR THE SAME PROFICIENCY SAMPLE. BIORAD EQAS (REFERENCE 12000815, LOT 330800) SAMPLE 8 RESULTS OF 0.19 AND 0.19 S/C (NEGATIVE) VERSUS AN 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 DISCORDANT, NEGATIVE VITROS AHIV RESULTS WERE FROM A NON-PATIENT FLUID AND WERE REPORTED TO THE PROFICIENCY PROVIDER. 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 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712320 ↗
• MalfunctionAug 3, 2023False Negative Result; False Negative Result

  THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS ANTI-HIV 1 & 2 (AHIV1+2) RESULTS WERE OBTAINED FROM TWO DIFFERENT LOTS OF VITROS AHIV1+2 REAGENT WHEN TESTING USING A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. VITROS ANTI-HIV 1 & 2 LOT 1110: VIROTROL I: VITROS AHIV1+2 ON INST J1 OF 0.58, 0.60, 0.57, 0.62, 0.60, 0.58, 0.61, 0.58, 0.57 AND 0.57 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VIROTROL I: VITROS AHIV1+2 ON INST J2 OF 0.42, 0.44, 0.53, 0.15, 0.15, 0.15, 0.57 AND 0.31 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VITROS ANTI-HIV 1 & 2 LOT 1100: VIROTROL II: VITROS AHIV1+2 ON INST J2 OF 0.44, 0.43 AND 0.44 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE NEGATIVE RESULTS OCCURRED ONLY OF QUALITY CONTROL FLUIDS. THE CUSTOMER PROCESSED PATIENT TESTING USING VITROS HIV1+2 LOT 1100 AND THERE WAS NO ALLEGATION OF PATIENT HARM. THE CUSTOMER DID NOT USE THE VITROS HIV1+2 LOT 1110 REAGENT LOT TO RUN PATIENT SAMPLES BECAUSE OF THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451636 ↗
• MalfunctionAug 3, 2023False Negative Result; False Negative Result

  THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS ANTI-HIV 1 & 2 (AHIV1+2) RESULTS WERE OBTAINED FROM TWO DIFFERENT LOTS OF VITROS AHIV1+2 REAGENT WHEN TESTING USING A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. VITROS ANTI-HIV 1 & 2 LOT 1110: VIROTROL I: VITROS AHIV1+2 ON INST J1 OF 0.58, 0.60, 0.57, 0.62, 0.60, 0.58, 0.61, 0.58, 0.57 AND 0.57 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VIROTROL I: VITROS AHIV1+2 ON INST J2 OF 0.42, 0.44, 0.53, 0.15, 0.15, 0.15, 0.57 AND 0.31 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VITROS ANTI-HIV 1 & 2 LOT 1100: VIROTROL II: VITROS AHIV1+2 ON INST J2 OF 0.44, 0.43 AND 0.44 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE NEGATIVE RESULTS OCCURRED ONLY OF QUALITY CONTROL FLUIDS. THE CUSTOMER PROCESSED PATIENT TESTING USING VITROS HIV1+2 LOT 1100 AND THERE WAS NO ALLEGATION OF PATIENT HARM. THE CUSTOMER DID NOT USE THE VITROS HIV1+2 LOT 1110 REAGENT LOT TO RUN PATIENT SAMPLES BECAUSE OF THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451555 ↗
• MalfunctionAug 3, 2023False Negative Result; False Negative Result

  THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS ANTI-HIV 1 & 2 (AHIV1+2) RESULTS WERE OBTAINED FROM TWO DIFFERENT LOTS OF VITROS AHIV1+2 REAGENT WHEN TESTING USING A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. VITROS ANTI-HIV 1 & 2 LOT 1110: VIROTROL I: VITROS AHIV1+2 ON INST J1 OF 0.58, 0.60, 0.57, 0.62, 0.60, 0.58, 0.61, 0.58, 0.57 AND 0.57 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VIROTROL I: VITROS AHIV1+2 ON INST J2 OF 0.42, 0.44, 0.53, 0.15, 0.15, 0.15, 0.57 AND 0.31 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) VITROS ANTI-HIV 1 & 2 LOT 1100: VIROTROL II: VITROS AHIV1+2 ON INST J2 OF 0.44, 0.43 AND 0.44 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE (>/=1.00) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE NEGATIVE RESULTS OCCURRED ONLY OF QUALITY CONTROL FLUIDS. THE CUSTOMER PROCESSED PATIENT TESTING USING VITROS HIV1+2 LOT 1100 AND THERE WAS NO ALLEGATION OF PATIENT HARM. THE CUSTOMER DID NOT USE THE VITROS HIV1+2 LOT 1110 REAGENT LOT TO RUN PATIENT SAMPLES BECAUSE OF THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451497 ↗