BEUDAMED
    FDA Recall Terminated

    1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA

    Recall: Z-0707-2007 · Initiated June 5, 2006

    Recall

    Recall Number
    Z-0707-2007
    Event Number
    37632
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2006
    Posted
    April 3, 2007
    Terminated
    June 25, 2007
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA

    Reason

    Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)

    Action

    Product recalled by letter dated 6/01/2006

    Distribution

    Worldwide Distribution-USA including states of UT, CO, IL, NY, NV, MI, NC, MN, VA, GA, CA, KS, VT, CT and IN, and Countries of Canada, Sweden, Germany, Belgium, Italy, France, Norway, Australia, South Korea, Taiwan, Israel, New Foundland, India, China, Brazil, Austria, Saudi Arabia, and Spain

    Quantity

    715