BEUDAMED
    FDA Recall Terminated

    Access Thyroglobulin, A34085G, Catalog No. 33860

    Recall: Z-2636-2017 · Initiated May 9, 2017

    Recall

    Recall Number
    Z-2636-2017
    Event Number
    77245
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    MSW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 9, 2017
    Terminated
    March 30, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Thyroglobulin, A34085G, Catalog No. 33860

    Reason

    The Access immunoassays are susceptible to biotin interference.

    Action

    An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. Customers are informed of the impact, action, and resolution. Customers are instructed to respond within 10 days: electronically via email or manually by completing and returning the enclosed response form. 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

    Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, Zimbabwe

    Quantity

    83,504 units total (23,285 units in US)