BEUDAMED
    FDA Recall Terminated

    BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.

    Recall: Z-1446-06 · Initiated June 1, 2005

    Recall

    Recall Number
    Z-1446-06
    Event Number
    35864
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    GKE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2005
    Posted
    August 26, 2006
    Terminated
    August 25, 2006
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.

    Reason

    Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis

    Action

    Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005

    Distribution

    World wide-USA, Canada, Europe, Asia Pacific.

    Quantity

    Lot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits