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.
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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