Official recall record
BD SARS-CoV-2 Reagents For BD Max System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-05-17
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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