STAT PROFILE PRIME CCS (REF 53418)Recalls & reported problems
Nova Biomedical Corporation · Remanufacture PRIME CCS Analyzer · Class 2
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 00385480534185), received between Apr 11, 2017 and Apr 11, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
1 other recall cover devices cleared under the same FDA submission (K141907); they may or may not involve this specific model.
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
- Excess Flow or Over-Infusion1
Patient problems
- Full thickness (Third Degree) Burn1
- Patient Problem/Medical Problem1
- Septic Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2017Excess Flow or Over-Infusion
PATIENT RECEIVED A BLOOD TRANSFUSION BASED UPON HEMATOCRIT AND HEMOGLOBIN (HCT & HB) RESULTS OBTAINED FROM THE PRIME CCS ANALYZER. SEE SUPPLEMENTAL REPORT.
Patient problems: Full thickness (Third Degree) Burn; Patient Problem/Medical Problem; Septic Shock
MAUDE report 6479646 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141907. One submission often covers many models, so check the product and lot details in each record.
- Z-2732-2017 · Jun 19, 2017 · TerminatedNova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime C
Other INSTRUMENT, HEMATOCRIT, AUTOMATED devices
- STAT PROFILE PRIME CCSNova Biomedical Corporation · INSTRUMENT, HEMATOCRIT, AUTOMATED1 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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