BD SARS-CoV-2 Reagents For BD Max System
Brand(s)
Last updated
Summary
Product
BD SARS-CoV-2 Reagents For BD Max System
Issue
Medical devices - Performance issue
COVID
What to do
Review notice & share with users/customers, identify & destroy affected product, complete/return reply form.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
BD SARS-CoV-2 Reagents For BD Max System |
3291356 |
445003-01 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
Becton Dickinson And Company (Bd)
7 Loveton Circle, Sparks, Maryland, United States, 21152
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75530
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