Events

Recall of Device Recall Sysmex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sysmex America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74654
  • Event Risk Class
    Class 2
  • Event Number
    Z-2770-2016
  • Event Initiated Date
    2016-07-01
  • Event Date Posted
    2016-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148122
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stains, hematology - Product Code KQC
  • 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.

Device

Device Recall Sysmex
  • Model / Serial
    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
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.
  • Product 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
  • Manufacturer
    Sysmex America Inc

Manufacturer

Sysmex America Inc
  • Manufacturer Address
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    USFDA