VITROS 6802156Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750002061), received between Aug 17, 2023 and Oct 11, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low 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. 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.

• MalfunctionOct 11, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT ¿ PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NON-VITROS MAS CARDIO-IMMUNE QUALITY CONTROL (QC) FLUID LOT OIM2503 ON A VITROS 5600 INTEGRATED SYSTEM. MAS QC LEVEL 2 RESULTS OF 307, 310.32, 312.70, 317.51 AND 320.22 PG/ML VS EXPECTED RESULT OF 428 PG/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 VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-PATIENT FLUID. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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 REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916053 ↗
• MalfunctionOct 11, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT ¿ PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NON-VITROS MAS CARDIO-IMMUNE QUALITY CONTROL (QC) FLUID LOT OIM2503 ON A VITROS 5600 INTEGRATED SYSTEM. MAS QC LEVEL 2 RESULTS OF 307, 310.32, 312.70, 317.51 AND 320.22 PG/ML VS EXPECTED RESULT OF 428 PG/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 VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-PATIENT FLUID. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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 REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916042 ↗
• MalfunctionAug 17, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A VITROS NTBNP II RANGE VERIFIER (RV) FLUID ON A VITROS 5600 INTEGRATED SYSTEM. VITROS NPBNP II RV RESULTS OF 14642.1, 14692.7, 15523.8, 15595.2 AND 16033.2 PG/ML VS EXPECTED RESULT OF 29400 PG/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 VITROS NTBNP II RESULT WAS OBTAINED WHEN PROCESSING VITROS NTBNP II NON-PATIENT FLUID. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. 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 17565319 ↗