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Health Canada Medical devices

Leukosure Enumeration Kit

Issued December 15, 2022
Issue
Affected lots of Leukosure enumeration kit may not be able to acquire 10,000 leukosure fluorosphere events within 300 seconds as outlined in the statement of warnings in the product instructions for use (IFU) pn 175624 revision ee. The issue is due to inadequate lysing of red blood cells. Recall start date: November 21, 2022
Hazard description
Performance
Product
Product name
Leukosure Enumeration Kit
Reference
ID
RA-72331