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.
Take action
Contact the company
📍Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607
“Staclot LA 20 Test Kits Recall: Shortened Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69473-staclot-la-20-test-kits-recall-shortened-results-risk. Based on FDA recall #Z-0611-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0611-2019%22&limit=1).
The FDA announced on Nov. 14, 2018, that Diagnostica Stago, Inc. recalled Staclot LA and Staclot LA 20 test kits due to reports of shortened results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Diagnostica Stago
Product names: Staclot LA, Staclot LA 20
Model number/REF: REF 00594
Lot codes: 251504, 251916, 252243, 252364, 252887, 253211
Quantity: 22,342 total units
The hazard
There have been reports of shortened (T1-T2) results, where some instances of result recovery occurred outside of the range of less than or equal to 15 seconds.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since Oct. 25, 2017. Other recent recalls include the STA Staclot Protein S Recall (July 29, 2026), the STA Liatest D-Di recall (Feb. 5, 2026), and the STA Liatest Free Protein S recall (Feb. 4, 2026). Other recent recalls of similar products include the Estrone RIA Kit Recall (Dec. 15, 2025), the ST AIA-Pack Testosterone Recall (June 12, 2026), and the Anti-TSHR Assay Recall (Nov. 21, 2025).
How to tell if you have this one
Check the lot numbers: 251504, 251916, 252243, 252364, 252887, 253211. The product is a reagent system for lupus anticoagulant testing in plasma.
Brand
Diagnostica Stago
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution
Recall number
Product, codes & lots
Z-0610-2019
Staclot¿ LA (REF 00600) 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).; Lot #s 251918, 252751
Z-0611-2019
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).; Lot #s 251504, 251916, 252243, 252364, 252887, 253211
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Look for the lot numbers 251504, 251916, 252243, 252364, 252887, or 253211 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0611-2019 (November 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0611-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.