BEUDAMED
    FDA Recall Terminated

    Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.

    Recall: Z-2324-2009 · Initiated June 4, 2009

    Recall

    Recall Number
    Z-2324-2009
    Event Number
    52813
    Firm
    Trek Diagnostic Systems
    FEI Number
    1000515493
    Product Code
    JTZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 4, 2009
    Posted
    September 30, 2009
    Terminated
    February 26, 2010
    Address
    982 Keynote Cir, Ste 6, Cleveland, OH, 44131-1873

    Description

    Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.

    Reason

    Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

    Action

    On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.

    Distribution

    Nationwide Distribution -- PA, VA & WA.

    Quantity

    31 boxes/10/11 ml tubes