Health Canada — Medical Devices · Canada · 2018-06-22 · Type III
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Through internal testing BD has determined that an enzyme used in the production of the dried PCR Master Mix reagent included in specific lots is not meeting performance expectations throughout its shelf life. Data indicate that enzyme residual activity may appear above expected levels.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.