BEUDAMED
    FDA Recall Terminated

    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

    Recall: Z-0173-2020 · Initiated May 9, 2019

    Recall

    Recall Number
    Z-0173-2020
    Event Number
    83793
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 9, 2019
    Terminated
    October 7, 2020
    Address
    4551 Great America Pkwy, Santa Clara, CA, 95054-1208

    Description

    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

    Reason

    The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.

    Action

    The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.

    Distribution

    Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.

    Quantity

    22 analyzers with tubing