Z-0611-2019Class II

Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the...

Name: Z-0611-2019 Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the...
Creator: Diagnostica Stago, Inc.
Published: 2018-11-14
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2018-11-14 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in... on 2018-11-14. FDA classified it as Class II and gives the reason as "There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0611-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Posted: 2018-12-14
Terminated: 2020-06-08
Recalling firm: Diagnostica Stago, Inc.
Product: Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Product code: GFO Activated Partial Thromboplastin
Reason for recall: There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, STAGO, sent a "Field Safety Notice" to its customers on 11/14/18. The notices describe the product, problem and actions to be taken. The customers were instructed to do the following: If you have any lots listed in the appendix in your laboratory, stop using and destroy the concerned kits; contact our sales administration team (1-800-222-2624 prompt #3) as soon as possible in order to obtain a replacement lot and complete the attached coupon acknowledging receipt of the letter. For additional information, please contact the STAGO hotline (1-800-725-0607) or email: [email protected] or 1-973-631-1200 ext 4104.
Quantity in commerce: 22342 total
Distribution: US Nationwide Distribution
Product codes and lots: Lot #s 251504, 251916, 252243, 252364, 252887, 253211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0611-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0610-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-14
Z-0611-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-14

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)