STAT PROFILE PHOX ULTRA CO OXRecalls & reported problems
Nova Biomedical Corporation · Stat Profile pHOx Ultra Co-Oximeter Analyzer · Class 1
All models of STAT PROFILE (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00385480420136), received between Jun 7, 2019 and May 23, 2022 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Misassembly During Maintenance/Repair” (12 reports).
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 18, 2026.
Most reported problems
Device problems
- Misassembly During Maintenance/Repair12
- Low Test Results10
- High Test Results6
- Incorrect, Inadequate or Imprecise Result or Readings3
Patient problems
- No Known Impact Or Consequence To Patient12
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THEIR PHOX ULTRA ANALYZER, SERIAL NUMBER (B)(4) GAVE A CRITICAL LOW ICA RESULT FOR A PATIENT. THE TEST WAS RUN ON (B)(6) 2022 USING ICA SENSOR LOT NUMBER 22033023. WHEN SAME SAMPLE WAS REPEATED ON A DIFFERENT PHOX ULTRA, THE RESULT WAS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14476543 ↗MalfunctionOct 9, 2019Incorrect, Inadequate or Imprecise Result or Readings
DISCREPANT PATIENT PH RESULT ON NOVA PHOX ULTRA COOX ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9171679 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680652 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA RESULT FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPRED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680650 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680648 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680647 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED HIGH CL RESULT FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680646 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA RESULT FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680645 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680644 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680643 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA RESULT FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680642 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA RESULT FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680641 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; High Test Results; Low Test Results; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Information
MAUDE report 8680634 ↗MalfunctionJun 7, 2019Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
ON (B)(6) 2019: CUSTOMER REPORTED LOW NA AND HIGH CL RESULTS FOR A PATIENT IN EMERGENCY DEPARTMENT USING A NOVA PHOX ULTRA COOX ANALYZER WHEN COMPARED TO THE LABORATORY REFERENCE ANALYZER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680632 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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