Becton Dickinson & Co. recalls BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervica…

Recall date

July 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0394-2018

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

US and OUS.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.