Z-0853-2007

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

Name: Z-0853-2007 STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand...
Creator: Diagnostica Stago, Inc.
Published: 2007-03-13
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2007-03-13 / Terminated / root cause: labeling and UDI

FDA source

Diagnostica Stago, Inc. began a recall of STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor on 2007-03-13. The reason FDA records is "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%". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0853-2007
Status: Terminated
Initiated: 2007-03-13
Posted: 2007-07-03
Terminated: 2009-01-16
Recalling firm: Diagnostica Stago, Inc.
Product: STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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%.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were notified on March 13, 2007 by letter, first class mail.
Quantity in commerce: 1,098 units
Distribution: Hospitals and laboratories Nationwide
Product codes and lots: Lot -- Exp: 052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.

Product code GGP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)