BEUDAMED
    FDA Recall Terminated

    Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

    Recall: Z-0541-2021 · Initiated August 13, 2020

    Recall

    Recall Number
    Z-0541-2021
    Event Number
    86255
    Firm
    Clinical Innovations, LLC
    FEI Number
    1000220650
    Product Code
    NQM
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 13, 2020
    Terminated
    May 24, 2024
    Address
    747 W 4170 S, Murray, UT, 84123-1364

    Description

    Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

    Reason

    Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.

    Action

    On August 17, 2020 through August 19, 2020, the firm sent an "URGENT SAFETY NOTICE" to customers via email informing them that the incorrect swabs (non-scored) were package with their in vitro diagnostic kits and that new instructions and training material will be provided. Customers are instructed to identify any affected products and to complete the response card that is attached to the Customer Notification Letter. Customers are also provided the option of returning the affected products to the Recalling Firm. A company representative will contact and arrange for the return of the product For any questions contact the Recalling Firm at +1-801-268-8200.

    Distribution

    US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None

    Quantity

    19450 units/kits