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Bd pcr cartridges 24
Official notice
2 Jan 2025
Last checked
2 Jan 2025
An official Health Canada notice concerns Bd pcr cartridges 24. 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 Published 2025-01-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76789
Official notice
2025-01-02
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Becton Dickinson And [bd], Bd Pcr Cartridges 24.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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