Z-1441-06

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

Name: Z-1441-06 Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay
Creator: Diagnostica Stago, Inc.
Published: 2006-07-18
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2006-07-18 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay on 2006-07-18. The reason FDA records is "Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1441-06
Status: Terminated
Initiated: 2006-07-18
Posted: 2006-08-26
Terminated: 2006-11-06
Recalling firm: Diagnostica Stago, Inc.
Product: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
FDA root cause: Other
Action: Recall notification letters were sent out via first class mail on July 18, 2006.
Quantity in commerce: 4,365 kits
Distribution: Nationwide
Product codes and lots: 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.

Product code GFO

K923731Class IIStaclot La Test KitAmerican Bioproducts Co. / cleared 1992-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)