BEUDAMED
    FDA Recall Terminated

    Access BR Monitor, Part No. 387620

    Recall: Z-2074-2017 · Initiated April 13, 2017

    Recall

    Recall Number
    Z-2074-2017
    Event Number
    77029
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    MOI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 13, 2017
    Terminated
    June 4, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access BR Monitor, Part No. 387620

    Reason

    Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).

    Action

    An urgent Medical Device Recall letter dated 4/13/17 was sent to customers following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU). Customers are informed of the impact and the actions to be taken. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.

    Distribution

    Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe

    Quantity

    45,278 units total (2,419 units in US)