Device product
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.
Z-0393-2018
Product summary
- Event
- Event 78808
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0393-2018
Official wording
Reason: 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.
Code information: UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.
Distribution pattern: US and OUS.
Derived failure modes
-
Unknown
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.