Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood Recalled by Nova Biomedical Corporation Due to Potential risk of reporting erroneous creatinine patient results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nova Biomedical Corporation directly.
Affected Products
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
Quantity: 1779 units: 438 US; 1341 OUS
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nova Biomedical Corporation
Nova Biomedical Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report