Diagnostica Stago, Inc. STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
Lot -- Exp: 052783 -- April 2007, 061242 -- November 2007, 061981 -- February 2008.
Products Sold
Lot -- Exp: 052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
Diagnostica Stago, Inc. is recalling STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Wil due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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%.
Recommended Action
Per FDA guidance
Customers were notified on March 13, 2007 by letter, first class mail.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026