VITROS 6801989Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750001750), received between Nov 8, 2024 and May 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULT WAS OBTAINED FROM A 10X DILUTION OF A PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE VITROS BENZ RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A POSITIVE RESULT OBTAINED USING THE SAME PATIENT SAMPLE TESTED UNDILUTED ON THE SAME VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE (TEST EVENT 2) RESULT OF < 850 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. IT WAS UNKNOWN IF THE DISCORDANT, NEGATIVE VITROS BENZ RESULT WAS 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 22014514 ↗
• MalfunctionNov 8, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT LOT: 1523-67-2046 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED TO BE FALSE NEGATIVES WHEN COMPARED TO RESULTS USING THE SAME SAMPLES FROM CONFIRMATORY TESTING USING GC/MS AND AN UNKNOWN REFERENCE METHOD. PATIENT 1 SAMPLE RESULT OF 143 NG/ML (NEGATIVE) VS AN EXPECTED RESULT OF POSITIVE PATIENT 2 SAMPLE RESULT OF 129 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 FALSE NEGATIVE VITROS BENZ RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED 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 TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639940 ↗
• MalfunctionNov 8, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT LOT 1523-67-2046 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED TO BE FALSE NEGATIVES WHEN COMPARED TO RESULTS USING THE SAME SAMPLES FROM CONFIRMATORY TESTING USING GC/MS AND AN UNKNOWN REFERENCE METHOD. PATIENT 1 SAMPLE RESULT OF 143 NG/ML (NEGATIVE) VS AN EXPECTED RESULT OF POSITIVE PATIENT 2 SAMPLE RESULT OF 129 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 FALSE NEGATIVE VITROS BENZ RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED 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 TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639756 ↗