STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- March 13, 2007
- Posted
- July 3, 2007
- Terminated
- January 16, 2009
- Recall Number
- Z-0853-2007
- Quantity
- 1,098 units
- Firm Location
- Parsippany, NJ
Reason for Recall
A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.
Distribution
Hospitals and laboratories Nationwide
Lot / Code Info
Lot -- Exp: 052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
Root Cause
Other
Action Taken
Customers were notified on March 13, 2007 by letter, first class mail.
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