BEUDAMED
    FDA Recall Terminated

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    Recall: Z-1078-2017 · Initiated November 29, 2016

    Recall

    Recall Number
    Z-1078-2017
    Event Number
    75818
    Firm
    Sekisui Diagnostics P.E.I. Inc.
    FEI Number
    3002806809
    Product Code
    JIF
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 29, 2016
    Posted
    January 23, 2017
    Terminated
    July 6, 2017
    Address
    70 Watts Ave, Charlottetown Canada

    Description

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    Reason

    Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

    Action

    Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email [email protected].

    Distribution

    Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka

    Quantity

    774 Liters bulk and 565 kits