FDA Device

Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

Hazard

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

What You Should Do

Remedy

Recall notification letters were sent out via first class mail on July 18, 2006.

Products

Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Brand
Diagnostica Stago, Inc.
UPC
Lot 050947D --exp. April 2007; Lot 051527A -- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007; Lot 051527D -- exp. June 2007.

Units Affected

4,365 kits