BEUDAMED
    FDA Recall Terminated

    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101

    Recall: Z-0082-2022 · Initiated November 1, 2019

    Recall

    Recall Number
    Z-0082-2022
    Event Number
    88652
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 1, 2019
    Terminated
    September 27, 2023
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    Description

    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101

    Reason

    A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.

    Action

    On 11/01/2019, ANA Screen Lot Matching-Compatibility Notice, were mailed to customers. Customers were advised of the following: If you have received the new control material, please ensure that your laboratory is using one of the newer lot numbers of BioPlex ANA calibrators and ANA reagents. Should you have any of the older BioPlex ANA reagent packs and calibrator sets listed below in ITALICS remaining in your inventory or if you have used these lots in combination with the new control, please contact your local Technical Support center. The following telephone number was provided: 510-724-7000.

    Distribution

    Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP, IL, SG, AU, NZ, HK, IT, CA, PT, GB, NO, CZ, SE, CH, UA, RU, BE, DK.

    Quantity

    206