Events

Recall of Device Recall COULTER HmX Hematology Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    58174
  • Event Risk Class
    Class 2
  • Event Number
    Z-2043-2011
  • Event Initiated Date
    2011-03-02
  • Event Date Posted
    2011-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98585
  • 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
    The recall was initiated because beckman coulter has identified a problem with integrated circuit chips used in different boards throughout the beckman coulter lh500/hmx/hmx autoloader hematology analyzer.
  • Action
    The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated March 2, 2011, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER¿ LH 500 Series Analyzer, COULTER¿ HmX Hematology Analyzer, and COULTER¿ HmX Hematology Analyzer with Autoloader. The letter described the product, problem and actions to be taken. Customers were informed that the suspect Integrated Circuit Chips have been removed from all systems in inventory and manufacturing. The customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers have forwarded any of the affected product(s) listed on the PCA letter to another laboratory, please provide a copy of the letter to them. The customers were instructed to complete and return the enclosed Response Form within 10 days so Beckman are assured they have received this important communication and are taking appropriate action. The customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States and Canada or contact their local Beckman Coulter Representative.

Device

Device Recall COULTER HmX Hematology Analyzer
  • Model / Serial
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.
  • Product Description
    COULTER¿ HmX Hematology Analyzer || Part number: 6605522, 6605523, 6605524 || The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA