BEUDAMED
    FDA Recall Terminated

    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    Recall: Z-0755-2007 · Initiated March 14, 2007

    Recall

    Recall Number
    Z-0755-2007
    Event Number
    37691
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LLM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 14, 2007
    Posted
    April 24, 2007
    Terminated
    July 15, 2007
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    Reason

    A lot to lot inconsistency was noted on kits of ETI EBNA G.

    Action

    All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product.

    Distribution

    Nationwide and Canada.

    Quantity

    203