FDAFDA · Food and drugs·Recall number Z-0951-2013
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
Published March 20, 2013 · Recall initiated: January 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Diagnostica Stago, Inc.
- Distributor
- Worldwide Distribution - USA and Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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