Events

Recall of Device Recall COULTER DxH Cell Lyse

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
    59726
  • Event Risk Class
    Class 2
  • Event Number
    Z-3263-2011
  • Event Initiated Date
    2011-07-11
  • Event Date Posted
    2011-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103461
  • 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
    Products, red-cell lysing products - Product Code GGK
  • Reason
    The recall was initiated because beckman coulter identified unexpected high particle counts in the lots of dxh cell lyse listed. these lots may generate high background counts; could result in a falsely elevated total nucleated count (tnc) of up to 50 cells/¿l; or may also result in recovery of tnc values that were higher than expected for level 1 of the body fluid control.
  • Action
    The recall communication was initiated on 08/01/2011 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US customers) to all customers, who purchased Coulter DxH Cell Lyse. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact Beckman Coulter for product replacement. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with 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 Beckman Coulter representative.

Device

Device Recall COULTER DxH Cell Lyse
  • Model / Serial
    Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and  0712002.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
  • Product Description
    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). || The COULTER¿ DxH Cell Lyse is an erythrocyte lytic agent used for quantitative || determination of hemoglobin, enumeration of NRBC, and counting and sizing || leukocytes on UniCel¿ DxH 800 Coulter¿ Cellular Analysis System.
  • 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