VITROS 6844294Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10758750031788), received between Aug 14, 2025 and Mar 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High 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.

• MalfunctionMar 5, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE XT (CREAXT) RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT TESTED ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS CREATINE RESULT OBTAINED FROM ONE OF THE SAMPLES AND VITROS CREAXT RESULTS OBTAINED FROM SAMPLES COLLECTED FROM THE SAME PATIENT WITHIN THE TIMEFRAME. (B)(6) PATIENT SAMPLE 1 VITROS CREAXT RESULT OF 2.7 MG/DL VS. THE SAMPLE 2 VITROS CREAXT RESULT OF 0.9 MG/DL (B)(6) PATIENT SAMPLE 3 VITROS CREAXT RESULT OF 2.1 MG/DL VS. THE SAMPLE 3 NON-VITROS CREATININE RESULT OF 1.1 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREAXT RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 ORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523905 ↗
• MalfunctionMar 5, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE XT (CREAXT) RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT TESTED ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS CREATINE RESULT OBTAINED FROM ONE OF THE SAMPLES AND VITROS CREAXT RESULTS OBTAINED FROM SAMPLES COLLECTED FROM THE SAME PATIENT WITHIN THE TIMEFRAME. (B)(6) PATIENT SAMPLE 1 VITROS CREAXT RESULT OF 2.7 MG/DL VS. THE SAMPLE 2 VITROS CREAXT RESULT OF 0.9 MG/DL (B)(6) PATIENT SAMPLE 3 VITROS CREAXT RESULT OF 2.1 MG/DL VS. THE SAMPLE 3 NON-VITROS CREATININE RESULT OF 1.1 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREAXT RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 ORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523897 ↗
• MalfunctionNov 21, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS XT CHEMISTRY PRODUCTS UREA-CREA SLIDES LOT: 7221-0020-2434 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO THE RESULT FROM THE SAME SAMPLE USING A NON-VITROS SIEMENS ATELLICA METHOD. PATIENT SAMPLE VITROS CREA RESULT OF 2.21 MG/DL VS AN EXPECTED RESULT OF 1.42 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED VITROS CREA RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621867 ↗
• MalfunctionOct 16, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE XT (CREAXT) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE. THE RESULTS WERE CONSIDERED HIGHER THAN EXPECTED WHEN COMPARED TO THE VITROS CREAXT RESULT OBTAINED FROM A SECOND SAMPLE COLLECTED FROM THE SAME PATIENT. VITROS CREA PATIENT SAMPLE 1 RESULTS OF 2.17 AND 1.85 MG/DL VS SAMPLE 2 VITROS CREAXT RESULT OF 0.91 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS CREAXT RESULT OF 2.17 MG/DL WAS REPORTED FROM THE LABORATORY, HOWEVER, NO TREATMENT WAS STOPPED, STARTED OR ALTERED. THE HIGHER-THAN-EXPECTED VITROS CREAXT RESULT OF 1.85 MG/DL WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 23310069 ↗
• MalfunctionAug 14, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS XT CHEMISTRY PRODUCTS UREA-CREA SLIDES LOT 7222-0021-3935 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS CREA RESULT OF <0.25 MG/DL VS AN EXPECTED RESULT OF 4.96 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULT, AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. A CORRECTED REPORT WAS LATER ISSUED FOR THE PATIENT. 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 ASSESSMENT 611632.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806684 ↗