VITROS 1072693Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750008360), received between Dec 19, 2025 and Jan 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionJan 8, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED NT-PROBNP II (NTBNP II) RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT QUALITY CONTROL (QC) FLUID LOT 1003102 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD QC LOT 1003102 QC FLUID RESULT OF 51.0 PG/ML VERSUS THE EXPECTED RESULT OF 153.2 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 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 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 24009234 ↗
• MalfunctionDec 19, 2025Low Test Results; Low Test Results

  THE INVESTIGATION HAS DETERMINED THAT A LOWER-THAN-EXPECTED NT PROBNP II (NTBNP II) RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS QUALAB BIOTECH QUALITY CONTROL (QC) FLUID LOT 2510A05423 ON A VITROS 5600 INTEGRATED SYSTEM. BIOTECH LOT 2510A05423 = 159.0 PG/ML VERSUS THE EXPECTED RESULT OF 352.67 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS NTBNP II RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS 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 23848556 ↗