BEUDAMED
    FDA Recall Terminated

    UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.

    Recall: Z-1088-2012 · Initiated January 11, 2012

    Recall

    Recall Number
    Z-1088-2012
    Event Number
    60967
    Firm
    Lab Vision Corporation
    FEI Number
    3000719701
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 11, 2012
    Posted
    February 22, 2012
    Terminated
    July 20, 2012
    Address
    46360 Fremont Blvd, Fremont, CA, 94538-6406

    Description

    UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.

    Reason

    Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.

    Action

    Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

    Distribution

    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.

    Quantity

    31 kits in total