Z-0350-2020 Class II Terminated

Recalled by Privapath Diagnostics Ltd — Dublin 12, N/A

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
July 1, 2019
Termination Date
November 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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 Pattern

Nationwide

Code Information

lot numbers: 1189 1094 144 226 82