VITROS 6801756Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10758750001309), received between May 24, 2023 and Jun 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. THE VITROS BENZ RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE POSITIVE RESULTS OBTAINED WHEN TESTING THE SAME PATIENT SAMPLE ON THE SAME VITROS XT7600 INTEGRATED SYSTEM. BENZ RESULT OF 172.85 NG/ML (NEGATIVE) VS AN 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, NEGATIVE VITROS BENZ RESULT WAS REPORTED FROM THE LABORATORY, AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN BASED ON THE PATIENT PRESENTATION AND CLINICAL HISTORY. A CORRECTED REPORT WAS ISSUED FOR >800 NG/ML (POSITIVE). THE CUSTOMER CONFIRMED THAT NO TREATMENT WAS STOPPED/ STARTED/ ALTERED BASED ON THE DISCORDANT NEGATIVE RESULT. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547578 ↗
• MalfunctionFeb 20, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 40450 QUALITY CONTROL USING VITROS PSA REAGENT LOT 4610 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMERS BASELINE MEAN. BIORAD LEVEL 3 VITROS PSA RESULTS OF 10.679, 10.652, 10.469, 10.258, 10.475 AND 10.745 NG/ML VS. THE EXPECTED PSA RESULT OF 14.35 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404179 ↗
• MalfunctionFeb 20, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 40450 QUALITY CONTROL USING VITROS PSA REAGENT LOT 4610 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMERS BASELINE MEAN. BIORAD LEVEL 3 VITROS PSA RESULTS OF 10.679, 10.652, 10.469, 10.258, 10.475 AND 10.745 NG/ML VS. THE EXPECTED PSA RESULT OF 14.35 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404012 ↗
• MalfunctionFeb 20, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 40450 QUALITY CONTROL USING VITROS PSA REAGENT LOT 4610 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMERS BASELINE MEAN. BIORAD LEVEL 3 VITROS PSA RESULTS OF 10.679, 10.652, 10.469, 10.258, 10.475 AND 10.745 NG/ML VS. THE EXPECTED PSA RESULT OF 14.35 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403848 ↗
• MalfunctionMay 24, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED QUALITY CONTROL RESULTS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS PSA (PSA) REAGENT IN COMBINATION WITH TWO VITROS XT 7600 INTEGRATED SYSTEMS. VITROS PSA REAGENT LOT 4290 ON VITROS XT 7600 INTEGRATED SYSTEM (J1): BIORAD IMMUNOASSAY PLUS CONTROL LEVEL 2 RESULTS OF 2.127, 2.139 AND 2.156 NG/ML VERSUS AN EXPECTED RESULT OF 3.100 NG/ML NO VITROS PSA RESULTS MET POTENTIAL HEALTH AND SAFETY CRITERIA FOR ON VITROS XT 7600 INTEGRATED SYSTEM (J2). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS PSA RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. 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 CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 602006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995038 ↗