BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

    Recall: Z-0806-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0806-2022
    Event ID
    89684
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    February 8, 2022
    Classification Date
    March 16, 2022
    Address
    6565 185th Ave Ne, N/A, Redmond, WA, 98052-5039, United States

    Description

    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

    Reason

    Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

    Code Info

    Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336

    Distribution

    Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.

    Quantity

    9,426 packs (U.S.)