Universal Sexual Health Testing Kit — Class II medical device recall Z-0350-2020
Terminated recall by Privapath Diagnostics Ltd, reported 2019-11-20, distributed nationwide. A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in bl
| Recall number | Z-0350-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Privapath Diagnostics Ltd, Dublin 12, N/A, Ireland |
| Recall initiated | 2019-07-01 |
| Classified | 2019-11-08 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-11-23 |
| Distributed | Nationwide (US) |
| Lot numbers | 1094, 1189, 144, 226 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0350-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.