FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
- Recall number
- Z-0853-2007
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
- Status
- Terminated
- Initiated
- 2007-03-13
- Posted
- 2007-07-03
- Terminated
- 2009-01-16
- Reason
- 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%.
- Root cause
- Other
- Action
- Customers were notified on March 13, 2007 by letter, first class mail.
- Quantity
- 1,098 units
- Distribution
- Hospitals and laboratories Nationwide
- Lot, serial or model codes
- Lot -- Exp: 052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GGP
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28