BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.

    Recall: Z-0578-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0578-2015
    Event ID
    69771
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    November 13, 2014
    Classification Date
    December 10, 2014
    Termination Date
    January 29, 2015
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.

    Reason

    Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.

    Code Info

    Lot number: 1374439, Exp: 31 Aug 2015

    Distribution

    Nationwide Distribution to FL

    Quantity

    1/10/100 ml/vials/packs