BEUDAMED
    FDA Recall 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 · Initiated April 28, 2017

    Recall

    Recall Number
    Z-2219-2017
    Event Number
    77260
    Firm
    Exact Sciences Corporation
    FEI Number
    3008256118
    Product Code
    PHP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 28, 2017
    Posted
    June 1, 2017
    Terminated
    August 11, 2017
    Address
    441 Charmany Dr, Madison, WI, 53719-1234

    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.

    Action

    Exact Sciences sent an Urgent Medical Device Correction letter dated April 28, 2017, via email to all affected consignees. The letter identified affected products and explained the issue. Exact Sciences personnel will correct each unit. Questions can be directed to 608-210-5183.

    Distribution

    US to WI only

    Quantity

    15