BEUDAMED
    FDA Enforcement Class II Terminated

    Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests

    Recall: Z-2219-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2219-2017
    Event ID
    77260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exact Sciences Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    June 1, 2017
    Termination Date
    August 11, 2017
    Address
    441 Charmany Dr, Madison, WI, 53719-1234, United States

    Description

    Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests

    Reason

    Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.

    Code Info

    Equipment ID / Serial Number: MIX-0051 / MX00002051, MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / MX00002052, MIX-0055 / MX00002043, MIX-0056 / MX00002040, MIX-0057 / MX00002050, MIX-0058 / MX00002036, MIX-0059 / MX00002027, MIX-0060 / MX00002015, MIX-0061 / MX00002016, MIX-0063 / MX00002039, MIX-0064 / MX00002033, MIX-0065 / MX00002053, MIX-0066 / MX00002014,

    Distribution

    US to WI only

    Quantity

    15