BEUDAMED
    FDA Recall Open, Classified

    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

    Recall: Z-1592-2024 · Initiated November 23, 2023

    Recall

    Recall Number
    Z-1592-2024
    Event Number
    93845
    Firm
    ACTIM OY Klovinpellontie 3 Espoo Finland
    FEI Number
    1000212994
    Product Code
    OAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 23, 2023
    Posted
    April 17, 2024

    Description

    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

    Reason

    Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

    Action

    Actim Oy issued a MEDICAL DEVICE RECALL notice to its sole distributor on 11/23/2023 via email. The notice explained the issue, potential risk, and requested that users refrain from using surgical lubricants when collecting the vaginal specimen and that vaginal specimens do not contain significant amounts of personal lubricant from patient's recent personal use. The instructions for use will be updated according to the latest test results of surgical and personal lubricant interference. In the interim, a separate note will be included in the test kit regarding the correction of the interference claims and guidance of lubricant use.

    Distribution

    US Nationwide distribution in the state of Connecticut.

    Quantity

    6471 kits