BEUDAMED
    FDA Enforcement Class II 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 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0173-2020
    Event ID
    83793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    May 9, 2019
    Classification Date
    October 22, 2019
    Termination Date
    October 7, 2020
    Address
    4551 Great America Pkwy, Santa Clara, CA, 95054-1208, United States

    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.

    Code Info

    Tubing lot #2018-10-16; Instrument serial numbers 007689, 007690, 007691, 007692, 007705, 007706, 007707, 007708, 007709, 007728, 007694, 007695, 007697, 007766, 007767, 007768, 007765, 007710, 007699, 007700, 007701, and 007703.

    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