BEUDAMED
    FDA Recall Terminated

    Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121

    Recall: Z-1352-2008 · Initiated December 4, 2007

    Recall

    Recall Number
    Z-1352-2008
    Event Number
    46307
    Firm
    Biosite Inc
    FEI Number
    1000125596
    Product Code
    MCB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 4, 2007
    Posted
    March 27, 2008
    Terminated
    March 20, 2012
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121

    Reason

    False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

    Action

    Consignees located in the United States received an Urgent Medical Device Recall Letter notification by United Parcel Service on 12/4/2007 and 12/14/2007. Consignees outside of the United States were notified by Federal Express on 12/4/2007 and 12/14/2007. The Customer Recall Letter with attached fax-back Verification form informed customers of the recall and instructed customers to dicontinue use, discard appropriately all affected kits and complete and FAX the enclosed Verification form. Contact information was also provided form the recalling firm. (USA-(800) 640-0640 )

    Distribution

    Worldwide- USA, Argentina, Australia, Belgium, Canada, Switzerland, Colombia, The Czech Republic, Germany, France, Greece, Guatemala, Hong Kong, Croatia, India, Italy, Mexico, Portugal, Sweden, Turkey & The United Kingdom

    Quantity

    4,549 kits