STAT PROFILE CCX CO OXRecalls & reported problems
Nova Biomedical Corporation · Stat Profile Critical Care Express CO-Oximeter Analyzer · Class 1
All models of STAT PROFILE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00385480374132), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- High Readings1
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 12, 2021High Readings; High Readings
ON FEBRUARY 22, THE CUSTOMER REPORTED THEY WERE RECEIVING HIGH VALUES FOR PCO2 ON THEIR STATPROFILE CCX +1, S/N (B)(4). THE USER REPORTED THE ANALYZER ALGORITHM WAS ADJUSTED UNTIL MAINTENANCE COULD BE PERFORMED. THE FACILITY IS CONTINUING TO USE THE INSTRUMENT THEREFORE IT WILL NOT BE RETURNED FOR EVALUATION. THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11474090 ↗
Other CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) devices
- STAT PROFILE PRIME CCS COMPNova Biomedical Corporation · CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)1 death7 reports
- Liquichek 511Bio-Rad Laboratories, Inc. · CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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