BEUDAMED
    FDA Recall Terminated

    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.

    Recall: Z-2887-2011 · Initiated May 31, 2011

    Recall

    Recall Number
    Z-2887-2011
    Event Number
    59016
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    May 31, 2011
    Posted
    July 27, 2011
    Terminated
    June 3, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92822-6232

    Description

    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.

    Reason

    The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.

    Action

    Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE/PRODUCT CORRECTION" letter dated May 31, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products. Customers were asked to complete and return an attached FAX BACK Response Form to 714-961-4234. Replacement products may be obtained by calling Order Assistance at 800-526-3821 in the United States, (800) 463-7828 in Canada or contacting your local Beckman Coulter representative. For any questions regarding this notice, contact the Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the United States and Canada; or contact your local sales representative.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Macao, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.

    Quantity

    6302 units (850 in the US)