FDA Device

STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.

Hazard

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%.

What You Should Do

Remedy

Customers were notified on March 13, 2007 by letter, first class mail.

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Products

STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
Brand
Diagnostica Stago, Inc.
UPC
Lot -- Exp:  052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.

Units Affected

1,098 units

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