Recall Z-0853-2007 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
| Date | Jul 3, 2007 (initiated Mar 13, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.