FDA-Device2018-01-31Class II
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.
Becton Dickinson & Co.
Hazard
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.
Sold states
US and OUS.
Affected count
N/A
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0394-2018Don't want to check this manually?
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