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Health Canada Medical devices

Epoc Bgem Bun Test Card [25pk]

Issued October 4, 2024
Issue
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some card lots approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/l. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. Please note the card lots identified are now expired. Recall start date: September 25, 2024
Hazard description
Performance
Product
Product name
Epoc Bgem Bun Test Card [25pk]
Reference
ID
RA-76285