STAT PROFILE PHOX ULTRARecalls & reported problems
Nova Biomedical Corporation · Stat Profile pHOx Ultra ABG Analyzer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00385480420143), received between Jul 26, 2018 and Sep 29, 2021 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
- Imprecise or Erratic Results3
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Information2
- Burn(s)1
- No Consequences Or Impact To Patient1
- Test Result1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Imprecise or Erratic Results; Imprecise or Erratic Results
THE CUSTOMER INDICATED THAT THEIR PHOX ULTRA ABG ANALYZER SERIAL NUMBER: (B)(6) REPORTED DISCREPANT CREATININE MEASUREMENT. THERE WAS NO PATIENT INJURY, HARM OR ADDITIONAL TREATMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12549588 ↗MalfunctionSep 29, 2021Imprecise or Erratic Results; Imprecise or Erratic Results
THE CUSTOMER INDICATED THAT THEIR PHOX ULTRA ABG ANALYZER SERIAL NUMBER: (B)(4) REPORTED DISCREPANT CREATININE MEASUREMENT. THERE WAS NO PATIENT INJURY, HARM OR ADDITIONAL TREATMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12548724 ↗MalfunctionSep 29, 2021Imprecise or Erratic Results; Imprecise or Erratic Results
THE CUSTOMER INDICATED THAT THEIR PHOX ULTRA ABG ANALYZER SERIAL NUMBER: (B)(4) REPORTED DISCREPANT CREATININE MEASUREMENT. THERE WAS NO PATIENT INJURY, HARM OR ADDITIONAL TREATMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547798 ↗MalfunctionNov 13, 2019Fitting Problem; Fitting Problem
CUSTOMER REPORTED THAT ELECTROLYTE VALUES ARE NOT MATCHING LAB REFERENCE ANALYZER RESULTS. NO PATIENT TREATMENT OR ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9317103 ↗MalfunctionJun 20, 2019Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2019: DISCREPANT NA PATIENT RESULTS BETWEEN NOVA PHOX ULTRA ANALYZER AND LABORATORY REFERENCE ANALYZER.
Patient problems: Test Result
MAUDE report 8716363 ↗MalfunctionJan 11, 2019Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2018: DISCREPANT CREATININE RESULTS FOR PATIENT IN CANCER CENTER WHEN COMPARED TO LAB.
Patient problems: No Information
MAUDE report 8241359 ↗MalfunctionJan 11, 2019Incorrect, Inadequate or Imprecise Result or Readings
(B)(6) 2018: DISCREPANT CREATININE RESULTS FOR PATIENT IN CANCER CENTER WHEN COMPARED TO LAB.
Patient problems: No Information
MAUDE report 8241317 ↗MalfunctionJul 26, 2018Incorrect, Inadequate or Imprecise Result or Readings
DISCREPANT GLUCOSE RESULTS ON NOVA PHOX ULTRA RESULTED IN PATIENT BEING TREATED WITH INSULIN.
Patient problems: Burn(s)
MAUDE report 7723809 ↗
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- Roche 9180 Electrolyte Analyzer 3157334001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, CALCIUM50 reports
- RAPIDLab® 1200 Series 1265 10321852Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, CALCIUM12 reports
- STAT PROFILE PRIME CCS COMPNova Biomedical Corporation · ELECTRODE, ION SPECIFIC, CALCIUM5 reports
- STAT PROFILE Prime CCS CompNova Biomedical Corporation · ELECTRODE, ION SPECIFIC, CALCIUM3 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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