BEUDAMED
    FDA Recall Open, Classified

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    Recall: Z-0297-2020 · Initiated February 27, 2018

    Recall

    Recall Number
    Z-0297-2020
    Event Number
    83925
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    JBD
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    February 27, 2018
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    Reason

    Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.

    Action

    On 2/27/2018, Helena's Technical Services contacted customer via phone call. In addition, consignees were emailed the recall notification. During the call/ communicated the following We would like to make you aware that you recently received a lot of SPIFE Alkaline Hemoglobin Gel kits, Catalog number 551977, which contained a revised procedural insert. This procedural version was released earlier than intended. The kits affected include the following lots: If you utilized the new testing parameters in the kit, the only noticeable effects would be increased pattern lengths, which would not affect quantitation or interpretation. Please discard the procedural inserts included in the kit received, and replace with the attached procedural insert(s), which contain the same instructions you have historically used: The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users -- as well as several improvements in the SPIFE Alkaline Hemoglobin gels that we anticipate will be released in the near future. At that time, additional instructions and information regarding the change will be made available to you. We apologize for any inconvenience this may have caused. Please contact Technical Services at 1-800-231-5663, EXT 1600 if you have any questions.

    Distribution

    US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan

    Quantity

    899 kits