BEUDAMED
    FDA Enforcement Class II 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 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2770-2016
    Event ID
    74654
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    September 9, 2016
    Termination Date
    February 10, 2017
    Address
    577 Aptakisic Rd, N/A, Lincolnshire, IL, 60069-4325, United States

    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.

    Code Info

    Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016

    Distribution

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

    Quantity

    3868 units