Events

Recall of Device Recall Sysmex XN10 and XN20 Hematology Analyzers

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

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
    70054
  • Event Risk Class
    Class 2
  • Event Number
    Z-1945-2016
  • Event Initiated Date
    2014-12-18
  • Event Date Posted
    2016-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132191
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    There is a potential for elevated hemoglobin (hgb) and impedance platelet count (plt-i) values.
  • Action
    Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abnormally elevated and may result in the results being flagged for verification or indicated to be outside of reference ranges; 3) Review any "Turbidity/Hgb Interf?" flag which will automatically trigger at an MCHC of 37.5 g/dL; 4) If Hgb is affected, the PLT-I may be also. Review any PLT-I result when an unexpected increase in MCH/MCHC or "Turbidity/Hgb Interf?" flag occurs; 5) Gross interference is likely to trigger a flag, however there is a potential any interference could increase the Hgb or the PLT-I count from a lower level to an "normal" level. Follow laboratory protocol for confirming unexpected results. Customers were further advised that they will be contacted by a Sysmex Field Representative within 180 days to schedule an appointment to replace the rinse cup on the analyzer(s) and that version 00-16 software will be installed to change the rinsing sequence for the aspiration probe. Customers with questions are requested to e-mail the Sysmex Technical Assistance Center. Urgent questions can be answered by calling the Technical Assistance Center at 888-879-7639 (24 hours a day / 7 days a week).

Device

Device Recall Sysmex XN10 and XN20 Hematology Analyzers
  • Model / Serial
    1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484;   2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.
  • Product Description
    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation
  • Manufacturer Address
    Sysmex Corporation, 1 5 1 Wakinohamakaigandoori, CHUO-KU, Kobe-shi Japan
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    USFDA