Device product
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
Z-0951-2013
Product summary
- Event
- Event 64320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2901 kits
- Official record key
device-enforcement:Z-0951-2013
Official wording
Reason: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Code information: 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 pattern: Worldwide Distribution - USA and Canada.
Derived failure modes
-
Unknown
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.