BD PCR Cartridges 24
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| BD PCR Cartridges 24 | More 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
Additional information
Details
| Becton Dickinson And Company (Bd) |
| 7 Loveton Circle, Sparks, Maryland, United States, 21152 |
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