BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (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 the BD MAX Vaginal Panel (Catalog Numbers 443712, 443710, 443711) used for collecting and transporting vaginal and endocervical swab specimens. In July 2017, the company notified customers that some were experiencing an increased rate of unresolved and indeterminate results when using this product. These non-reportable results could require patients to repeat testing or provide new specimen samples.
The affected product was distributed in the United States and outside the United States. The recall document does not specify a remedy or recommended action for consumers who may have been affected by this product.
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: Not Distributed in US Not Distributed in US
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.