BEUDAMED
    FDA Recall Terminated

    SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    Recall: Z-0461-2012 · Initiated November 14, 2011

    Recall

    Recall Number
    Z-0461-2012
    Event Number
    60542
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    NYQ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 14, 2011
    Posted
    January 11, 2012
    Terminated
    February 10, 2012
    Address
    7305 Executive Way, Frederick, MD, 21704-8354

    Description

    SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    Reason

    In vitro diagnostic reagent may be contaminated with a fungal contaminant.

    Action

    Life Technologies sent an URGENT DEVICE RECALL letter dated November 14, 2011 by mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return remaining inventory. Customers were advised to complete the Customer Response Sheet included for recovering inventory data and fax back to (+1) 716-774-6727 Technical Support or e-mail to [email protected]. Customers who had distributed the affected kits outside of their facility were instructed to immediately notify their customers of the recall. For questions call Technical Support, at (+1) 800-955-6288 opt. 2 then opt. 3.

    Distribution

    Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.

    Quantity

    29 kits