BEUDAMED
    FDA Enforcement Class II Terminated

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    Recall: Z-2361-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2361-2020
    Event ID
    85533
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abaxis Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2020
    Initiation Date
    December 11, 2019
    Classification Date
    June 12, 2020
    Termination Date
    July 22, 2022
    Address
    3240 Whipple Rd, Union City, CA, 94587-1217, United States

    Description

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    Reason

    Incorrect reference ranges of analytes.

    Code Info

    Model Number: 1100-0000; 1100-0001; Software version 2.1.55 (NGA models )/3.1.35(Jen II models) Serial Numbers:0000000P23019, 0000000P02700 0000000P22997, 0000000P24435 0000000P05910 0000000P05380 0000000P08467 0000000P06595 0000000P07622 0000000P07988 0000000P04609 0000000P24721 0000000P24495 0000000P20399 0000000P20131 0000000P02755

    Distribution

    All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.

    Quantity

    15