BEUDAMED
    FDA Enforcement Class II Terminated

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    Recall: Z-2656-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2656-2017
    Event ID
    77464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    JAS Diagnostics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    April 21, 2017
    Classification Date
    June 30, 2017
    Termination Date
    January 6, 2020
    Address
    14100 NW 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    Description

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    Reason

    May result in elevated platelet backgrounds during routine startup/background checks.

    Code Info

    Lot # 0868 Exp. Date 11/28/2018, Lot # 0869 & Lot 0870 Exp. Date 01/10/2019, Lot # 0871,0872, 0873, 0874 , 0875, and 0876 Exp. Date 02/06/2019, and Lot # 0877, 0877, 0879, 0880, 0881, and 0882 Exp. Date 02/23/2019

    Distribution

    AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam

    Quantity

    14,064