BEUDAMED
    FDA Enforcement Class II 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 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1328-2013
    Event ID
    64910
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iris Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    September 18, 2012
    Classification Date
    May 15, 2013
    Termination Date
    January 27, 2014
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805, United States

    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.

    Code Info

    Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013

    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