BEUDAMED
    FDA Recall Completed

    Sysmex Fluorocell(R) PLT 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-0045-2018 · Initiated September 8, 2017

    Recall

    Recall Number
    Z-0045-2018
    Event Number
    78134
    Firm
    Sysmex America, Inc.
    FEI Number
    3009711478
    Product Code
    KQC
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 8, 2017
    Posted
    October 16, 2017
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Sysmex Fluorocell(R) PLT 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 potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.

    Action

    Sysmex sent a Customer Letter dated August 2017 to all affected customers. The customer was directed to examine their inventory for the affected lot numbers and report back to Sysmex. .Customers with questions should call 1-888-879-7639, option 2 (if within the U.S.) or 1-888-679-7639 (for customers in Canada)

    Distribution

    Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica

    Quantity

    23,239 units (9353 US)