[Recalled] Universal Sexual Health Testing Kit — A supplier informed PrivaPath Diagnostics that there is a potential for damaged… | FDA 2019-07-01
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Universal Sexual Health Testing Kit |
|---|---|
| Brand / manufacturer | Privapath Diagnostics Ltd |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0350-2020 |
| Country of notice | Ireland |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 July 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Ireland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.