FDA Device

Universal Sexual Health Testing Kit

Hazard

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.

What You Should Do

Remedy

PrivaPath Diagnostics telephoned and or issued emails to all customers and stated the following: PrivaPath Diagnostics has not received any reports from any customers or laboratory partners regarding this issue and the telephone call/email is just a precautionary action. However, PrivaPath Diagnostics PrivaPath Diagnostics is working closely with the supplier to ensure that this issue does not recur. If contact has been unsuccessful the customer will be sent a second email. This action ensures that in the case of a potential erroneous result it is followed up upon either through a replacement kit with LetsGetChecked with an unaffected lot number or with another healthcare provider.

Products

Universal Sexual Health Testing Kit
Brand
Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin
UPC
lot numbers: 1189  1094 144 226 82