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Health Canada Medical devices

Biofire® Respiratory Panel 2.1 (Rp2.1)

Issued June 1, 2023
Issue
Biomerieux identified a manufacturing event that may contribute to elevated rates of false negative results while using the Biofire RP2.1 panel. Biomerieux has not received any false negative complaints from the field but, out of an abundance of caution, Biomerieux is recalling the product that was manufactured during this event. Recall start date: May 16, 2023
Hazard description
Performance
Product
Product name
Biofire® Respiratory Panel 2.1 (Rp2.1)
Reference
ID
RA-73737