BEUDAMED
    FDA Recall Terminated

    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.

    Recall: Z-2953-2018 · Initiated July 27, 2018

    Recall

    Recall Number
    Z-2953-2018
    Event Number
    80716
    Firm
    Sysmex America, Inc.
    FEI Number
    3009711478
    Product Code
    KQC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 27, 2018
    Terminated
    July 8, 2019
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.

    Reason

    The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.

    Action

    The firm, Sysmex, issued a "Product Notifications" letter dated 7/2018 via U.S. mail on 7/27/2018 to the consignees who received the affected lots. The letter was also issued to all other XN-Series customers with registered email addresses with the Sysmex Customer Resource Center via email blast on 7/27/2018 who did not directly receive the affected lots but could have received them through other channels. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. follow your internal procedures for evaluation of flagged results. 2. Distribute this Product Notification to the appropriate personnel to take the following actions: 3. Upon receipt of unaffected lots of replacement reagent, immediately exchange any affected Fluorocell PLT cartridges currently in use on your analyzer. 4. Discard any remaining affected lots in inventory according to your laboratorys protocols and procedures. 5.Please proceed to the URL: http://pages.sysmex.com/fluorocellrecall.html to complete the Fluorocell Recall Response Form. Confirm receipt and understanding of the Product Notification. Sysmex will replace the quantity of affected lot(s) identified in this Product Notification that are confirmed to be currently in your inventory. If you have any questions concerning this information, please contact Sysmex Quality Assurance Department at [email protected].

    Distribution

    Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.

    Quantity

    5,168 units