BEUDAMED
    FDA Recall Terminated

    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    Recall: Z-1523-2016 · Initiated March 31, 2016

    Recall

    Recall Number
    Z-1523-2016
    Event Number
    73752
    Firm
    Biocare Medical, LLC
    FEI Number
    3004140393
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 31, 2016
    Terminated
    June 20, 2016
    Address
    4040 Pike Ln, Concord, CA, 94520-1227

    Description

    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    Reason

    Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.

    Action

    Biocare Medical sent a Medical Device Recall Notification letter dated March 31, 2016 to affected US customers by USPS. Foreign consignees were also notified per their various government regulations. The letter identified the affected product, problem and actions to be taken. Customers were requested to complete and return by April 15, 2016 the enclosed Return Response Form.

    Distribution

    US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva

    Quantity

    93