# FDA recall Z-0350-2020

> **Privapath Diagnostics Ltd** · Class II · device recall initiated 2019-07-01.

## 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

- **Recall number:** Z-0350-2020
- **Recalling firm:** Privapath Diagnostics Ltd
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0350-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0350-2020. Source: US FDA. Licensed CC0.

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