BEUDAMED
    FDA Recall Open, Classified

    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

    Recall: Z-2982-2020 · Initiated April 21, 2020

    Recall

    Recall Number
    Z-2982-2020
    Event Number
    85636
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    LIP
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 21, 2020
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    Description

    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

    Reason

    The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.

    Action

    Consignees that have purchased active lots of the BioPlex 2200 Syphilis Total and RPR kit have been notified of the Field Correction via a customer letter sent via Fed Ex overnight ; date issued 04/21/2020. The communication was to inform that the RPR portion of the BioPlex 2200 Syphilis Total & RPR assay will be temporarily disabled. The RPR assay will be disabled beginning with reagent lot 301142 of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). The reporting of the RPR assay results will be disabled by the installation of a new assay protocol file (APF). The communication includes that there are no modifications to the chemistry of the assay reagents or processing of the assay by the BioPlex 2200 System. The RPR assay will remain disabled until further notice. Consignees are asked to complete and return the Customer Response form (fax: 1-888-228-0688/email: [email protected]) to confirm receipt of the communication and to receive instructions for installation of the new APF; return the form within 10 days of receiving the notice. Additionally, consignees are asked to contact their local technical support if there are any questions about the notification.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB).

    Quantity

    12000 kits