BEUDAMED
    FDA Enforcement Class II Terminated

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

    Recall: Z-1050-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1050-2019
    Event ID
    82214
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LW Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 3, 2019
    Initiation Date
    February 6, 2019
    Classification Date
    March 22, 2019
    Termination Date
    May 7, 2021
    Address
    865 Marathon Pkwy, N/A, Lawrenceville, GA, 30046-2857, United States

    Description

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

    Reason

    The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.

    Code Info

    Serial Numbers: 6C1803035, 6C1803066, 6C1803121, 6C1803130, 6C1803132, 6C1803133, 6C1803139, 6C1803141, 6C1803142, 6C1803144, 6C1803145, 6C1805217, 6C1805242, 6C1805243, 6C1810375, 6C1810441

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Philippines, Honduras, El Salvador, Australia, Guatemala, Canada, Singapore, Australia, Peru, Nicaragua, Trinidad and Tobago, and New Zealand

    Quantity

    16 units