BEUDAMED
    FDA Recall Terminated

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    Recall: Z-1576-2016 · Initiated March 10, 2016

    Recall

    Recall Number
    Z-1576-2016
    Event Number
    73650
    Firm
    Jas Diagnostics/Drew Scientific
    FEI Number
    3003071743
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 10, 2016
    Terminated
    August 21, 2019
    Address
    14100 NW 57th Ct, Miami Lakes, FL, 33014-3107

    Description

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    Reason

    The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.

    Action

    JAS Diagnostics/ Drew Scientifics sent an Important Product Advisory letter dated March 10, 2016, to all affected customers. The domestic customers were notified via letter and international customers were notified via email. Customers were instructed to contact Drew Scientific Inc. Customer Service or Technical Service at 1-800-433-0945 for product replacement. The firm suggested a temporary workaround of performing five background runs three times per day in order to ensure background counts are running within specification.

    Distribution

    Worldwide Distribution - US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX. and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.

    Quantity

    7,691