Enforcement Report - Week of March 20, 2013
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Product Detail
| Product 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 Asnières sur Seine (France) Coagulation Assay |
|---|---|
| Recall Number | Z-0951-2013 |
| Classification | Class II |
| 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 |
| Product Distributed Qty | 2901 kits |
| Reason For Recall | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. |
Event Detail
| Event Id | 64320 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Diagnostica Stago, Inc. |
| City | Parsippany |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-28 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - USA and Canada. |
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