Health Canada — Medical Devices · Canada · 2025-01-02 · Type II
🏛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 →
Archived by the issuing authority — kept for reference
Reported risk: BD has identified through customer complaint investigations, that signal drift has been observed in specific lots of BD PCR cartridges. BD has identified the following impacts: • for the BD Max™ RVP assay (catalog # 445215 & 445373) signal drift could cause false positive results for Influenza A. • for specific BD Max™ molecular assays including enteric bacterial panel (EBP, catalog #442963), enteric parasite panel (EPP, catalog #442960), StaphSR (catalog #443419), MDR-TB (catalog #443878), CPO (catalog # 445262) signal drift could potentially cause an increase in unresolved results (UNR). • for the BD COR™ VP (catalog # 443976) signal drift could potentially cause an increase in unresolved results (UNR). • for third-party assays used with the open system reagent kits (BD MAX™ ExK™ DNA- 1, DNA-2, DNA-3, DNA MMK, DNA MMK (SPC), TNA MMK, TNA MMK (sSPCpc), TNA-2 and TNA-3) signal drift could potentially cause an increase in unresolved results (UNR) or unexpected results. Recall start date: December 19, 2024
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.