FDA recall Z-0350-2020

Product

Universal Sexual Health Testing Kit

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-07-01

Report date

2019-11-20

Termination date

2020-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin 12, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0350-2020