BEUDAMED
    FDA Recall Terminated

    Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.

    Recall: Z-2920-2020 · Initiated July 23, 2020

    Recall

    Recall Number
    Z-2920-2020
    Event Number
    86109
    Firm
    Remel Europe Ltd. Clipper Boulevard West Dartford United Kingdom
    FEI Number
    3003750284
    Product Code
    GOY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 23, 2020
    Terminated
    March 22, 2022

    Description

    Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.

    Reason

    Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

    Action

    On July 23, 2020, Thermo Scientific issued a Medical Device field action recall on behalf of the Foreign Manufacturer of the affected product, Remel Europe Ltd . The notification states the following action to be taken: 1. The firm requests that you destroy any remaining inventory of the lot listed and contact Technical Services regarding any necessary replacements. 2. Requirement for review of reported test results should be determined by the appropriate technical expert. 3. Please keep this notification on file. 4. Complete the accompanying Acknowledgment Form upon receipt and return to [email protected]. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.

    Quantity

    79 units