BEUDAMED
    FDA Recall Terminated

    Fluorocell PLT reagent, Catalog #CD994563 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-2770-2016 · Initiated July 1, 2016

    Recall

    Recall Number
    Z-2770-2016
    Event Number
    74654
    Firm
    Sysmex America Inc
    FEI Number
    3009711478
    Product Code
    KQC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 1, 2016
    Posted
    September 9, 2016
    Terminated
    February 10, 2017
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Fluorocell PLT reagent, Catalog #CD994563 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

    There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.

    Action

    Sysmex sent a Product Notification Letter dated August 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . Customers were instructed to cease use and discard the affected lots, and reply to Sysmex America, Inc. using the provided fax-back form. An updated Product Notification (Attachment 1) was mailed to all XN-Series customers on August 12, 2016 informing them of the additional recalled lots. This notification included the phone number for the Technical Assistance Center at 1-888-879-7639 in the U.S., and 1-888-679-7639 in Canada.

    Distribution

    Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.

    Quantity

    3868 units