BEUDAMED
    FDA Recall Terminated

    Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,

    Recall: Z-1400-2017 · Initiated February 9, 2017

    Recall

    Recall Number
    Z-1400-2017
    Event Number
    76445
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    LKA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 9, 2017
    Terminated
    May 1, 2019
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,

    Reason

    Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.

    Action

    Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm. If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International) For further questions, please call (913) 895-4077.

    Distribution

    USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.

    Quantity

    RO4033 - 163, R01503 - 50.