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Nova Biomedical Corporation recalls Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,
Recalled November 8, 2023 · FDA recall Z-0208-2024 · Nova Biomedical
Hazard
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. · FDA Class II
Units
161 units
Sold at
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Description
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.
Product
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
Manufacturer(s)
Nova Biomedical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →