Device evidence

device-recall:cfres:203428

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

Official recall number

Z-0207-2024

Evidence summary

Product code: JGS
Recall status: Open, Classified
Event initiated: September 18, 2023
Root cause: Process design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0207-2024