BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

    Recall: Z-0200-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0200-2015
    Event ID
    69521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    October 17, 2014
    Classification Date
    November 10, 2014
    Termination Date
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

    Reason

    Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.

    Code Info

    Lot Number: 1451506 Expiration: 26Feb2016

    Distribution

    Distributed in the states of ND, VT and TX.

    Quantity

    16/10/100 ml, vial, pkgs