BEUDAMED
    FDA Recall Terminated

    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

    Recall: Z-1469-2020 · Initiated August 12, 2018

    Recall

    Recall Number
    Z-1469-2020
    Event Number
    84899
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    GRP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 12, 2018
    Terminated
    January 20, 2022
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

    Reason

    A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.

    Action

    On XXX, an Urgent Field Safety Notice was sent via email to customers. Customers are instructed to discontinue using this product immediately; dispose of any remaining product at your facility following local regulations; discuss this information with your medical director so that the potential impact of the issue is considered on a local level; and to return the completed and signed E-Back form TSWS18 to [email protected] or to your local firm representative within one week of receiving this notification. Customers are also requested to include a witness signature for the kit disposal as this is required on the E-Back form. Customers with additional questions were encouraged to email [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.

    Quantity

    462 kits