BEUDAMED
    FDA Recall Terminated

    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.

    Recall: Z-1743-2011 · Initiated June 21, 2010

    Recall

    Recall Number
    Z-1743-2011
    Event Number
    56397
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2010
    Posted
    March 22, 2011
    Terminated
    July 2, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.

    Reason

    The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date.

    Action

    The firm Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated June 25, 2010 to the consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: *Discontinue use and discard appropriately Rheumatoid Factor (RF) reagent lot M907325 *Contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss reagent replacement options. *Complete and return the FAX BACK RESPONSE FORM via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., Brea, California 92821, Mail Code E2.SE.08 Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If consignees/customers forwarded the affected products listed above to another laboratory, then they need to also provide a copy of the Product Corrective Action letter to the laboratory. If they have any questions regarding this Product Corrective Action letter, consignees were told to call Beckman Coulter Customer Support Center (Hotline) at (800) 854-633 in the United States and Canada.

    Distribution

    Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    58 units