RecallDepth

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

Company
Diagnostica Stago, Inc.
Recall Initiated
July 18, 2006
Posted
August 26, 2006
Terminated
November 6, 2006
Recall Number
Z-1441-06
Quantity
4,365 kits
Firm Location
Parsippany, NJ

Reason for Recall

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

Distribution

Nationwide

Lot / Code Info

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.

Root Cause

Other

Action Taken

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

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