Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (Rp2.1) [Model No.: 423742; Lot No./ Serial No.: 2168222] [HKMD No.: 210367].
According to Health Canada, the manufacturer identified a manufacturing event that may contribute to elevated rates of false negative results while using the Biofire RP2.1 panel. The manufacturer is recalling the product that was manufactured during this event.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/biofirer-respiratory-panel-21-rp21
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 Jun 2023