Diagnostica Stago, Inc. Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Diagnostica Stago, Inc. is recalling Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. due to Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
Recommended Action
Per FDA guidance
Recall notification letters were sent out via first class mail on July 18, 2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026