BEUDAMED
    FDA Recall Terminated

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    Recall: Z-0951-2013 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0951-2013
    Event Number
    64320
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GJT
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    January 28, 2013
    Posted
    March 14, 2013
    Terminated
    July 19, 2013
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    Reason

    Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

    Action

    Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.

    Distribution

    Worldwide Distribution - USA and Canada.

    Quantity

    2901 kits