BEUDAMED
    FDA Recall Terminated

    Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

    Recall: Z-1888-2017 · Initiated March 24, 2017

    Recall

    Recall Number
    Z-1888-2017
    Event Number
    76846
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSH
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 24, 2017
    Posted
    April 27, 2017
    Terminated
    June 6, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

    Reason

    Confirmed complaint of surface contamination of Listeria monocytogenes.

    Action

    On 3/24/2017, the recalling firm sent a recall notice to their customers explaining the reason for the recall and instructing customers to review their stock and discard any affected product. The notice also instructed customers to advise of the recall anyone they may have further distributed the recalled lot to. Attached to the recall notice is a response form which the recalling firm instructed their consignees to fill out and return.

    Distribution

    US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico

    Quantity

    1,159/100 plates/packs