Events

Recall of Device Recall Sysmex XN Series Automated Hematology Analyzers

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
    76828
  • Event Risk Class
    Class 2
  • Event Number
    Z-2034-2017
  • Event Initiated Date
    2017-03-23
  • Event Date Posted
    2017-04-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154358
  • 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
    Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. completed capa identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
  • Action
    Sysmex sent an Field Correction letter dated April 2017. Product will not be returned, but corrected at the customer site. The correction requires a service visit that will be documented in the Sysmex service Customer Relationship Management (CRM) software. The service report is accepted by the customer at the time of service. Completion of the service records will be tracked by reports generated from the Service CRM. For further Technical Assistance or questions please call (1 888) 879-7639.

Device

Device Recall Sysmex XN Series Automated Hematology Analyzers
  • Model / Serial
    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada
  • Product Description
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  • 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