BEUDAMED
    FDA Recall Terminated

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    Recall: Z-0775-2014 · Initiated December 6, 2013

    Recall

    Recall Number
    Z-0775-2014
    Event Number
    67065
    Firm
    Lab Vision Corporation
    FEI Number
    3000719701
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 6, 2013
    Posted
    January 16, 2014
    Terminated
    February 25, 2014
    Address
    46117 Landing Pkwy, Fremont, CA, 94538-6407

    Description

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    Reason

    Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

    Action

    Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.

    Distribution

    Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.

    Quantity

    5