The Recall Desk
HighFDA (Devices)·Z-0350-2020·Announced 2019-11-20

PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of blood exposure and erroneous medical results, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

PrivaPath Diagnostics Ltd is recalling Universal Sexual Health Testing Kits nationwide. The recall was initiated after a supplier informed the company that there is a potential for damaged tubes in the product.

The damaged tubes could result in blood exposure or erroneous test results due to an inappropriate blood-to-additive ratio. The affected lot numbers are 1189, 1094, 144, 226, and 82.

Consumers who have purchased these kits should check their lot numbers and stop using the product if it matches the affected lots. The source text does not specify further instructions for disposal or replacement.

The recalled product

Product
Universal Sexual Health Testing Kit
Manufacturer
Privapath Diagnostics Ltd
Category
Medical Device — Diagnostic Test Kit
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot numbers: 1189 1094 144 226 82

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · blood exposure

See all →