BEUDAMED
    FDA Recall Terminated

    UniCel DxC 600 The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

    Recall: Z-2081-2011 · Initiated October 22, 2010

    Recall

    Recall Number
    Z-2081-2011
    Event Number
    57779
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    October 22, 2010
    Posted
    April 26, 2011
    Terminated
    September 2, 2014
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    UniCel DxC 600 The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

    Reason

    This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.

    Action

    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.

    Distribution

    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    4879 units total (3490 in US)