BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. recalled BD MAX CT/GC/TV specimen collection and transport kits (catalog numbers 443824, 442970, and 443590) after notifying customers in July 2017 of an increased rate of unresolved and indeterminate results when using the BD MAX Vaginal Panel. Non-reportable results may require customers to repeat testing and/or recollect specimens. The recalled products were distributed in the US and outside the US across all lot numbers.
The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Reason for recall: BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen. Distribution: US and OUS. Quantity: N/A Lot/code info: UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.