Events

Recall of Device Recall Coulter HmX Hematology Analyzer and 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
    57757
  • Event Risk Class
    Class 2
  • Event Number
    Z-1730-2011
  • Event Initiated Date
    2010-12-14
  • Event Date Posted
    2011-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97337
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    The recall was initiated because beckman coulter has confirmed the coulter maxm, maxm al, hmx and hmx al analyzers omit the tilde (~) character when the tilde is used as part of the sample 10 within a barcode label scanned by the primary mode barcode reader. there is a potential for specimen or patient misidentification to occur.
  • Action
    The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Device

Device Recall Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader
  • Model / Serial
    All serial numbers.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
  • Product Description
    Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. || Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. || 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