BEUDAMED
    FDA Recall 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 · Initiated November 13, 2014

    Recall

    Recall Number
    Z-0578-2015
    Event Number
    69771
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 13, 2014
    Posted
    December 12, 2014
    Terminated
    January 29, 2015
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.

    Distribution

    Nationwide Distribution to FL

    Quantity

    1/10/100 ml/vials/packs