BEUDAMED
    FDA Recall Terminated

    The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

    Recall: Z-2247-2016 · Initiated June 27, 2016

    Recall

    Recall Number
    Z-2247-2016
    Event Number
    74559
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LDT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2016
    Posted
    July 20, 2016
    Terminated
    August 25, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

    Reason

    Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

    Action

    A Customer notification letter dated 6/27/16 informs their customers that Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. The letter informs their customers that the DxC No Foam reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the hydropneumatic subsystems. Over time, this incompatibility may lead to: Breaks in No Foam Cap Assembly (PN A84827) and Cracks in No Foam Waste Collector (PN A60007/A64665). The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the recall notice are instructed to contact our Customer Support Center Via http://www.beckmancoulter.com/customersupport/support Via phone, call 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Affected geographies: United Arab Emirates, Curacao, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brunei, Canada, Switzerland, Colombia, Costa Rica, Czech Republic, Germany, Ecuador, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Ireland, India, Iraq, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Macao, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, China, United States of America (including Puerto Rico), Viet Nam, Mayotte, South Africa.

    Quantity

    4,221 units total (2,033 units in US)