Events

Recall of UniCel DxH 800 Coulter Cellular Analysis System

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
    58584
  • Event Risk Class
    Class 2
  • Event Number
    Z-2227-2011
  • Event Initiated Date
    2011-04-14
  • Event Date Posted
    2011-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99629
  • 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 auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.
  • Action
    The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel¿ DxH" 800 Coulter¿ Cellular Analysis System PN 629029. The letter provides customers with an explanation of the problem identified and an action to be taken. For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. Ensure an alternative method of analysis is available during database maintenance. For Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report. Instead, submit the missing file(s) by one of the following methods: - Submit your data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) - Fax printouts of the missing files to 786-639-3999 - Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. - Include the IQAP number on any communication. A corrected report will be returned to the customers' laboratories. For issue 4, customers were instructed to submit their control data to IQAP by one of the following methods: -Submit their data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) -Fax printouts of the missing files to 786-639-3999 -Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. -Include your IQAP number on any communication. Customers were instructed to complete and return the enclosed Response Form within ten days. Customers were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Device

UniCel DxH 800 Coulter Cellular Analysis System
  • Model / Serial
    Part # 629029
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Product Description
    Unicel¿ DxH 800 Coulter¿ Cellular Analysis System. || A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found 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