FDA recall Z-0394-2018

Becton Dickinson & Co. · Class II · device

Product

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.

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.

Key facts

Status
Terminated
Initiation date
2017-07-18
Report date
2018-01-31
Termination date
2018-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0394-2018