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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