BEUDAMED
    FDA Recall Terminated

    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.

    Recall: Z-0046-2013 · Initiated July 24, 2012

    Recall

    Recall Number
    Z-0046-2013
    Event Number
    63169
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 24, 2012
    Posted
    October 10, 2012
    Terminated
    October 17, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.

    Reason

    Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

    Action

    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated July 24, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to complete and return the enclosed Response Forms within 10 days. Customers with questions were instructed to call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter representative.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.

    Quantity

    4,635 units total (3,214 units in US)