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STAT PROFILE CCXRecalls & reported problems

Nova Biomedical Corporation · Stat Profile Critical Care Express Analyzer · 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 00385480359429), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 17, 2018Adverse Event Without Identified Device or Use Problem

    PT SCHEDULED FOR R&L HEART CATH POC CREATININE RAN IN UNIT AND RESULTED AT 1.7, PROCEDURE DELAYED FOR HYDRATION THERAPY.

    Patient problems: No Code Available

    MAUDE report 7694958 ↗

Other ELECTRODE, ION-SPECIFIC, CHLORIDE devices

All ELECTRODE, ION-SPECIFIC, CHLORIDE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.