Privapath Diagnostics Ltd: Medical Device Recall in 2019 - (Recall #: Z-0350-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Universal Sexual Health Testing Kit

Product Classification:

Class II

Date Initiated: July 1, 2019

Date Posted: November 20, 2019

Recall Number: Z-0350-2020

Event ID: 83709

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.

Status: Terminated

Product Quantity: N/A

Code Information:

lot numbers: 1189 1094 144 226 82

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated