Official recall record
BD PCR Cartridges 24
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Record last checked against the registry on 2026-05-31.