STAT PROFILE PRIME CCS COMP (REF 53657)Recalls & reported problems
Nova Biomedical Corporation · Prime CCS Comp w/ Scanner Analyzer · Class 1
All models of STAT PROFILE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00385480536578), received between Sep 29, 2020 and Oct 22, 2024 — classified as 1 death, 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “High Test Results” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results3
- Low Test Results3
- Inability to Irrigate1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Aneurysm1
- Exposure to Body Fluids1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
DeathOct 22, 2024Low Test Results; Low Test Results
ON (B)(6) 2024 PATIENT WAS ADMITTED WITH AN ANEURYSM AND UNDERWENT CARDIAC SURGERY TO PLACE VALVES (UNSPECIFIED). LOW PCO2 RESULT INCOMPATIBLE WITH THE PATIENT'S CLINIC. PATIENT EXPIRED THURSDAY EVENING (B)(6) 2024.
Patient problems: Aneurysm
MAUDE report 20511410 ↗InjuryDec 9, 2022Inability to Irrigate; Inability to Irrigate
THE OPERATOR OF THE DEVICE SUSTAINED EYE EXPOSURE TO FLUSH FLUID WHEN ATTEMPTING TO CLEAR A VISIBLE CLOT IN THE PROBE OF THE ANALYZER. THE OPERATOR WAS NOT WEARING EYE PROTECTION.
Patient problems: Exposure to Body Fluids
MAUDE report 15952812 ↗MalfunctionApr 5, 2022Low Test Results; Low Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014720 ↗MalfunctionApr 5, 2022Low Test Results; Low Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014669 ↗MalfunctionApr 5, 2022High Test Results; High Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014485 ↗MalfunctionApr 5, 2022High Test Results; High Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014402 ↗MalfunctionSep 29, 2020High Test Results; High Test Results
CUSTOMER REPORTED ON (B)(6) 2020 THAT PCO2 PATIENT RESULTS OBTAINED ON A NOVA PRIME CCS COMP W/SCANNER ANALYZER SN (B)(4) WERE HIGH COMPARED TO THEIR LAB ANALYZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10601007 ↗
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 CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) devices
- Liquichek 511Bio-Rad Laboratories, Inc. · CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)1 report
- STAT PROFILE CCX CO OXNova Biomedical Corporation · 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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