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
RecallTracker