BEUDAMED
    FDA Recall Terminated

    Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.

    Recall: Z-1327-2009 · Initiated March 14, 2008

    Recall

    Recall Number
    Z-1327-2009
    Event Number
    47475
    Firm
    Diagnostic Chemicals, Ltd.
    FEI Number
    3002806809
    Product Code
    JMO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 14, 2008
    Posted
    May 13, 2009
    Terminated
    May 16, 2012
    Address
    16 McCarville Street, Charlottetown Canada Prince Edward Island

    Description

    Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.

    Reason

    Precipitate in product may cause elevated background absorbance interference.

    Action

    Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.

    Distribution

    Nationwide Distribution

    Quantity

    153 kits