Z-0393-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- July 18, 2017
- Termination Date
- July 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
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 Pattern
US and OUS.
Code Information
UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.