BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 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 UVE Specimen Collection Kit (Catalog Number 443376) after notifying customers in July 2017 of an increased rate of unresolved and indeterminate results when used with the BD MAX Vaginal Panel. Non-reportable results may require patients to repeat the test or provide a new specimen. The recall affects all lot numbers of this product when used with certain companion kits and was distributed in the United States and internationally.
The source does not specify a remedy or recommended action for consumers who may have been affected by this recall.
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 when used with catalog 443712, 443824 and 442970.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.