BEUDAMED
    FDA Recall Terminated

    Universal Sexual Health Testing Kit

    Recall: Z-0350-2020 · Initiated July 1, 2019

    Recall

    Recall Number
    Z-0350-2020
    Event Number
    83709
    Firm
    Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin
    FEI Number
    3015209536
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 1, 2019
    Terminated
    November 23, 2020
    Address
    12 Ireland

    Description

    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.

    Action

    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.

    Distribution

    Nationwide