VITROS 1204247Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products Calibrator Kit 6 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750008520), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS CREATINE KINASE MB (CKMB) RESULT OBTAINED FROM A SINGLE VITROS ISOENZYME (ISO) PERFORMANCE VERIFIER (PV) I (LOT: Y2755) USING VITROS CKMB SLIDE LOT: 4926-0279-3242 ON A VITROS 350 CHEMISTRY SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE MIDPOINT OF THE RANGE OF MEANS (MROM) FOR VITROS ISO PV I LOT: Y2755. VITROS ISO PVI (LOT: Y2755) RESULT OF 14.0 U/L VS. THE EXPECTED RESULT OF 26.3 U/L 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 CKMB RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. ALTHOUGH THE ISSUE WAS ISOLATED TO THE VITROS PVI CONTROL FLUID IN USE IN THE CUSTOMER LABORATORY, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621812 ↗
Other DIAZO COLORIMETRY, BILIRUBIN devices
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- VITROS 8383051Ortho-Clinical Diagnostics, Inc. · DIAZO COLORIMETRY, BILIRUBIN1 recall5 reports
- VITROS 1612365Ortho-Clinical Diagnostics, Inc. · DIAZO COLORIMETRY, BILIRUBIN1 recall1 report
- ARCHITECT 6L45-21Abbott Laboratories · DIAZO COLORIMETRY, BILIRUBIN46 reports
- ARCHITECT 6L45-22Abbott GmbH · DIAZO COLORIMETRY, BILIRUBIN30 reports
- ARCHITECT 6L45-41Abbott Laboratories · DIAZO COLORIMETRY, BILIRUBIN18 reports
- Bilirubin Direct Gen.2 08056951190Roche Diagnostics GmbH · DIAZO COLORIMETRY, BILIRUBIN17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.