FDA-Device2019-11-20Class II
Universal Sexual Health Testing Kit
Privapath Diagnostics Ltd
Hazard
A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.
Sold states
Nationwide
Affected count
N/A
Manufactured in
Unit A10 Block A, Calmount Park; Calmount Avenue, Dublin 12, N/A, Ireland
Products
Universal Sexual Health Testing Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0350-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief