Product Wiki · Recalls · Health Canada — Medical Devices

BD SARS-CoV-2 Reagents For BD Max System — recall 75530

Health Canada — Medical Devices · Canada · 2024-05-17 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75530
Date of alert
2024-05-17
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Pathology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-sars-cov-2-reagents-bd-max-

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