FDA Device recall Z-0350-2020
Universal Sexual Health Testing Kit
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Universal Sexual Health Testing Kit by Privapath Diagnostics, citing 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-ad….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0350-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-01 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Privapath Diagnostics |
| Distribution | US |
Product
Universal Sexual Health Testing Kit
Reason
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.
Identifiers
| code_info | lot numbers: 1189 1094 144 226 82 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0350-2020%22
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