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Health Canada Medical devices

Ortho Connect

Issued May 9, 2025
Issue
An assay rule was created for profile anti-A that was defined with assay anti-A has a grade between 0 and <= 3+ to hold pending review and to notify. When the result for anti-A was received with a grade of 3+, the result did not trigger the rule as was expected. Recall Start Date: April 1, 2025
Hazard description
Performance
Product
Product name
Ortho Connect
Reference
ID
RA-77428