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Health Canada Medical devices

Stat Profile Prime® Plus Analyzer

Issued November 20, 2023
Issue
Nova Biomedical became aware of a 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. Recall start date: September 13, 2023
Hazard description
Performance
Product
Product name
Stat Profile Prime® Plus Analyzer
Reference
ID
RA-74618