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Health Canada Medical devices

BD SARS-CoV-2 Reagents For BD Max System

Issued May 17, 2024
Issue
BD has identified, through an internal investigation, that the BD Max SARS-CoV-2 Assays, may produce false negative results due to decreased activity of the enzyme utilized in the manufacture of this assay's master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted. Recall Start Date: May 7, 2024
Hazard description
Performance - COVID
Product
Product name
BD SARS-CoV-2 Reagents For BD Max System
Reference
ID
RA-75530