Reported Mar 20, 2013 · Terminated
Vial Label
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
Vial Label
3 of 3 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
- Lot/Unit NumbersCombination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿
- VWFAG are involved. Lot Number Expiry date
1081282013-031085122013-041087782013-071094152013-101095912014-01
- Amount recalled
- 2901 kits
Why it was recalled
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
This product could cause temporary or reversible health problems — stop using it.
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