BEUDAMED
    FDA Recall Terminated

    IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.

    Recall: Z-2184-2011 · Initiated March 30, 2011

    Recall

    Recall Number
    Z-2184-2011
    Event Number
    58583
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CFL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 30, 2011
    Posted
    May 11, 2011
    Terminated
    December 2, 2011
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.

    Reason

    The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).

    Action

    Beckman Coulter sent a Product Corrective Action (PCA) letter with attached customer response form on March 30, 2011 to all customers who have the affected product, IGFBP- 3 Enzyme-Linked immunosorbent Assay ( ELISA) kit .This kit provides materials for the quantitative measurement of IGFBP-3 in serum. The letter informed the customers of the reason for recall, the products affected and actions to be taken. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they were asked to provide a copy of the letter to them. Beckman further asked consignees to complete and return the enclosed Response Form within 10 days so they are assured consignees have received this important communication. Questions were directed to the Beckman Coulter Customer Support Center. - Website: http://www.beckmancoulter.com/customersupport/support - Phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada contact local Beckman Coulter representative.

    Distribution

    Worldwide -- USA, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Italy, Korea, Republic of, Lebanon, Luxembourg, Morocco, Netherlands, New Zealand, Puerto Rico, Syrian Arab Republic, Taiwan, Thailand, Turkey & United Kingdom

    Quantity

    1,212 units