BEUDAMED
    FDA Recall 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 · Initiated February 6, 2019

    Recall

    Recall Number
    Z-1050-2019
    Event Number
    82214
    Firm
    LW Scientific, Inc.
    FEI Number
    3000251573
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2019
    Terminated
    May 7, 2021
    Address
    865 Marathon Pkwy, Lawrenceville, GA, 30046-2857

    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.

    Action

    The recall was initiated by telephone on 02/06/2019. Initial requesting that the consignee immediately cease use of the product. Recall notices were disseminated by telephone and email requesting the return of the product beginning 02/13/2019. The recall is to the user level. The firm has posted a notice on their website stating there is a voluntary recall due to a safety issue and asking users to call if they have a unit purchased after 9/28/18.

    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