Nova Biomedical Corporation: 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 Anal

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Republic Ecuador Egypt El Salvador Finland France Germany Greece Guatemala India Indonesia Ireland Israel Italy Japan JORDAN Kazakhstan Kenya Kurdistan, Iraq Kuwait Malaysia Malta Mexico Moldova Morocco Nepal Netherlands New Zealand Oman Pakistan Palestine Paraguay Quantity: 1779 units: 438 US; 1341 OUS Lot/code info: UDI-DI: (1) 00385480574006 (2) 00385480595087 All software versions (V1.17.1123.0 and V3.2.1123.0)

UPC codes

00385480574006, 00385480595087

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.