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Health Canada Medical devices

IH-500

Issued October 13, 2022
Issue
In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e". Recall start date: September 23, 2022
Hazard description
Performance
Product
Product name
IH-500
Reference
ID
RA-72020