BEUDAMED
    FDA Enforcement Class II 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 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1576-2016
    Event ID
    73650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Jas Diagnostics/Drew Scientific
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 10, 2016
    Classification Date
    April 27, 2016
    Termination Date
    August 21, 2019
    Address
    14100 NW 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    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.

    Code Info

    Lot # 0825, exp 01/06/2018; Lot # 0826, exp 01/06/2018; Lot # 0827, exp 01/06/2018; Lot # 0828, exp 01/21/2018; Lot # 0829, exp 01/21/2018; Lot # 0830, exp 01/21/2018; Lot # 0831, exp 01/21/2018; and Lot # 0832, exp 01/21/2018.

    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