Official recall record
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-18
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Nova Biomedical Corporation
What the authority reported
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. - 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. - 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
All 9 official recall notices naming Nova Biomedical Corporation on this site →
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