BEUDAMED
    FDA Enforcement Class II 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 Asni¿res sur Seine (France) Coagulation Assay

    Recall: Z-0951-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0951-2013
    Event ID
    64320
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 20, 2013
    Initiation Date
    January 28, 2013
    Classification Date
    March 14, 2013
    Termination Date
    July 19, 2013
    Address
    5 Century Dr, N/A, Parsippany, NJ, 07054-4607, United States

    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 Asni¿res 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.

    Code Info

    Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01

    Distribution

    Worldwide Distribution - USA and Canada.

    Quantity

    2901 kits