Recall Monitor
Health Products

BD PCR Cartridges 24

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: BD PCR Cartridges 24
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
BD PCR Cartridges 24More than 10 numbers, contact manufacturer.437519

Issue

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

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