Events

Recall of Coulter HmX Hematology Analyzer with Autoloader

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
    60367
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2012
  • Event Initiated Date
    2011-10-13
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105176
  • 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 has identified a problem with integrated circuit chips used in different boards throughout the analyzer.
  • Action
    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form.

Device

Coulter HmX Hematology Analyzer with Autoloader
  • Model / Serial
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Coulter ¿ HmX Hematology Analyzer with Autoloader, || Part number: 6605525, 6605526, 6605527. || HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. 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., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA