VITROS 6802413BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750009862), received between Jan 9, 2024 and Mar 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS NA+ SLIDES LOT 4208-1093-4724 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS NA+ PATIENT RESULT OF 156 MMOL/L VERSUS THE EXPECTED (REPEAT) RESULT OF 129 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED PATIENT SAMPLE 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) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951007 ↗
• MalfunctionJan 9, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4218-1101-9460 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 201.0 MMOL/L VS AN EXPECTED RESULT OF 129.0 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER THE PHYSICIAN QUESTIONED THE RESULT AND NO TREATMENT WAS ADMINISTERED OR ALTERED. 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476507 ↗