BEUDAMED
    FDA Recall Terminated

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    Recall: Z-1328-2013 · Initiated September 18, 2012

    Recall

    Recall Number
    Z-1328-2013
    Event Number
    64910
    Firm
    Iris Diagnostics
    FEI Number
    2023446
    Product Code
    JJW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 18, 2012
    Posted
    May 15, 2013
    Terminated
    January 27, 2014
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805

    Description

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    Reason

    The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.

    Action

    IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.

    Quantity

    942 boxes