BEUDAMED
    FDA Recall Terminated

    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

    Recall: Z-0529-2019 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-0529-2019
    Event Number
    81303
    Firm
    Helena Laboratories, Inc.
    FEI Number
    1618982
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 7, 2016
    Terminated
    January 15, 2021
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

    Reason

    Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.

    Action

    On 11/02/2016, the firm, Helena Laboratories, Inc., sent a "Withdrawal Notification" to customers via email. The notice described the product, problem and actions to be taken. The customers were instructed remove lot from inventory and discard; contact technical services at 1-800-231-5663 ext.1600 for MRA#; and complete Withdrawal Notification form and return copy to Helena Laboratories via FAX at:409-842-1874 or email to: [email protected]. The firm is doing a Withdrawal of this lot, and will replace this material, if they have not already done so, with a new kit lot. If the customer indicates how many kits it has remaining, the firm will forward replacement, under Material Return Authorization and to use an enclosed form to report replacement needs. Customers are informed to contact Technical Services is 1-800-231-5663, Ext. 1600; for MRA#, and for questions, to contact Jessica Jones at extension 1177, or email [email protected]. The firm's public contact may be reached at (409)842-3714 extension 1177.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.

    Quantity

    43 kits (6 kits Domestic/37 Internationally)