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Terminated

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

FDA Recall Z-0853-2007 · Posted 2007-07-03

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGGP
Date Initiated2007-03-13
Date Terminated2009-01-16
Product Quantity1,098 units

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%.

Firm Action

Customers were notified on March 13, 2007 by letter, first class mail.

Root Cause

Other

Distribution Pattern

Hospitals and laboratories Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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