BEUDAMED
    FDA Recall Terminated

    GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.

    Recall: Z-1914-2010 · Initiated October 12, 2009

    Recall

    Recall Number
    Z-1914-2010
    Event Number
    53698
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    CIB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 12, 2009
    Posted
    June 28, 2010
    Terminated
    April 17, 2012
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.

    Reason

    The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.

    Action

    Consignees were Emailed or faxed a "DiaSorin Customer Notification" letter dated October 21, 2009. The letter was addressed to "Dear Valued Customer". The letter described the Product name and the problem and provided the correct range for the Renin Activity Control provided with the kit. The letter also stated that replacement product for any previous failed runs. Customers are to complete the bottom portion of the letter and return it to the firm. Questions or concerns should be directed to DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.

    Distribution

    Worldwide Distribution -- USA, including states of CA, CT, IN, LA, MI, NC, OH, TN, UT, and WA and countries of CANADA, BELGIUM, BRAZIL, INDIA, NORWAY, PORTUGAL, SPAIN, and SWEDEN.

    Quantity

    289 kits