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Health Canada Medical devices

Quantum Blue Adalimumab Assay

Issued December 8, 2021
Issue
Premature instability of Quantum Blue® Adalimumab Lot Series 3410 leading to an overestimation of Adalimumab trough levels with an approximate bias of +50%. Recall start date: Nov 25, 2021
Hazard description
Premature failure
Product
Product name
Quantum Blue Adalimumab Assay
Reference
ID
RA-63694