Privapath Diagnostics Ltd recalls Universal Sexual Health Testing Kit

Recall date

July 1, 2019

Source

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

Recall number

Z-0350-2020

FDA classification

Class II

Brand / firm

Privapath Diagnostics Ltd

Sold / distributed

Nationwide

Why it was recalled

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.

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

What was recalled

Universal Sexual Health Testing Kit