BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2656-2017 · Initiated April 21, 2017

    Recall

    Recall Number
    Z-2656-2017
    Event Number
    77464
    Firm
    JAS Diagnostics Inc.
    FEI Number
    3003071743
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 21, 2017
    Terminated
    January 6, 2020
    Address
    14100 NW 57th Ct, Miami Lakes, FL, 33014-3107

    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.

    Action

    The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.

    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