BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0541-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0541-2021
    Event ID
    86255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2020
    Initiation Date
    August 13, 2020
    Classification Date
    December 7, 2020
    Termination Date
    May 24, 2024
    Address
    747 W 4170 S, N/A, Murray, UT, 84123-1364, United States

    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.

    Code Info

    Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631

    Distribution

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

    Quantity

    19450 units/kits