Recall Z-0853-2007
Diagnostica Stago, Inc. · initiated March 13, 2007
Product
STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
Codes / lots: Lot -- Exp: 052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
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%.
FDA-determined cause: Other
Action taken
Customers were notified on March 13, 2007 by letter, first class mail.
Details
- Recall number
- Z-0853-2007
- Initiated
- March 13, 2007
- Posted by FDA
- July 3, 2007
- Terminated
- January 16, 2009
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Quantity
- 1,098 units
- Distribution
- Hospitals and laboratories Nationwide
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ