BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2227-2011 · Initiated April 14, 2011

    Recall

    Recall Number
    Z-2227-2011
    Event Number
    58584
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 14, 2011
    Posted
    May 20, 2011
    Terminated
    May 23, 2012
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    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 [email protected]. - 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 [email protected]. -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.

    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.

    Quantity

    673 units