Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin Universal Sexual Health Testing Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Universal Sexual Health Testing Kit
Brand
Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin
Lot Codes / Batch Numbers
lot numbers: 1189 1094 144 226 82
Products Sold
lot numbers: 1189 1094 144 226 82
Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin is recalling Universal Sexual Health Testing Kit due to A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026