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Health Canada Medical devices

Epoc Blood Analysis Bgem Test Cards

Issued June 20, 2022
Issue
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-250 mmhg). Recall start date: June 8, 2022
Hazard description
Performance
Product
Product name
Epoc Blood Analysis Bgem Test Cards
Reference
ID
RA-64288