VITROS 6801697Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750006618), received between Aug 23, 2024 and Jun 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 4, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-34-2390 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL LOT 56750 CONTROL AND A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUID ON TWO DIFFERENT VITROS XT7600 SYSTEMS. J76001978 BIORAD L2 VITROS VALP RESULTS OF 538.1 AND 538.1 UMOL/L VS. THE VITROS PEER MEAN OF 448.1 UMOL/L. J76001977 BIORAD L2 VITROS VALP RESULT OF 357.8 UMOL/L VS. THE VITROS PEER MEAN OF 448.1 UMOL/L. VITROS TDM D2151 RESULT OF 398.28 UMOL/L VS. THE EXPECTED RESULT OF 517.0 UMOL/L. THE HIGHER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. 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 NUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143497 ↗
• MalfunctionJan 10, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AS WELL AS FROM AN ADMIXTURE OF PATIENT SAMPLES AND INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. IQMH/PATIENT SAMPLE ADMIXTURE 1 RESULT OF 404? MOL/L VERSUS THE EXPECTED REPEAT RESULT OF 331? MOL/L IQMH/PATIENT SAMPLE ADMIXTURE 6 RESULT OF 471? MOL/L VERSUS THE EXPECTED REPEAT RESULT OF 383? MOL/L BIORAD QC LEVEL 2 RESULTS 649, 620, 623, 631, 638, AND 639 UMOL/L WHEN COMPARED TO THE BR LEVEL 2 PEER MEAN OF 515.7 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED RESULTS WERE FROM AN ADMIXTURE OF IQMH PROFICIENCY SAMPLES AND PATIENT SAMPLES AND THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124559 ↗
• MalfunctionAug 23, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-34-2390 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J1) PATIENT 2 SAMPLE RESULT OF 545.10 UMOL/L VS AN EXPECTED RESULT OF 437.40 UMOL/L VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J2) PATIENT 4 SAMPLE RESULT OF 312.10 UMOL/L VS AN EXPECTED RESULT OF 237.10 UMOL/L PATIENT 8 SAMPLE RESULT OF 452.90 UMOL/L VS AN EXPECTED RESULT OF 365.80 UMOL/L PATIENT 9 SAMPLE RESULT OF 607.90 UMOL/L VS AN EXPECTED RESULT OF 501.80 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED RESULTS WERE FROM PATIENT SAMPLES THAT WERE PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053870 ↗