BEUDAMED
    FDA Recall 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 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-0200-2015
    Event Number
    69521
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 17, 2014
    Posted
    November 10, 2014
    Terminated
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.

    Distribution

    Distributed in the states of ND, VT and TX.

    Quantity

    16/10/100 ml, vial, pkgs