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Health Canada Medical devices

Ih-Qc 3

Issued May 3, 2022
Issue
Following customers' feedback, we have been able to confirm that the results obtained with this Ih-Qc 3 batch may not be as expected. Different issues were observed which may cause Qc failed results: a. Positive reactions may be observed in Direct Antiglobulin Tests (DAT) b. Weaker or in worse case false negative reactions may occur with Rh:4 cells in Indirect Antiglobulin Test (IAT) and in 2-stage papain technique c. When testing the impacted batch of Ih-Qc3 with Id-cards containing Anti-C, a double population with Anti-C (Rh:4) can be observed Recall start date: Apr 25, 2022
Hazard description
Increased risk or new adverse events
Product
Product name
Ih-Qc 3
Reference
ID
RA-64140