BEUDAMED
    FDA Recall Terminated

    DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.

    Recall: Z-0705-05 · Initiated June 30, 2004

    Recall

    Recall Number
    Z-0705-05
    Event Number
    30936
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LCI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2004
    Posted
    April 13, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.

    Reason

    An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.

    Action

    A customer notification letter was sent to customers 6/30/04. The letter identified theproduct, problem and the correct expiration date. Customers were instructed to complete the response form on the lower portion of the notification and fax it back to DiaSorin.

    Distribution

    MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland

    Quantity

    181