STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
FDA device recall Z-0853-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- 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%.
- Action taken
- Customers were notified on March 13, 2007 by letter, first class mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- 1,098 units
- Distribution
- Hospitals and laboratories Nationwide
- Date initiated
- 2007-03-13
- Date posted
- 2007-07-03
- Date terminated
- 2009-01-16
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.