Lower riskMedical device recall · FDA · Published September 12, 2025
Diagnostica Stago STA Liatest D-Di Recall: Risk of Underestimating D-Dimer Levels
Diagnostica Stago recalls STA Liatest D-Di test kits with specific lot numbers due to potential underestimation of D-Dimer levels. Affected users should check their lot numbers and contact the manufacturer for guidance.
“Diagnostica Stago STA Liatest D-Di Recall: Risk of Underestimating D-Dimer Levels.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51307-diagnostica-stago-sta-liatest-d-di-recall-risk-of-underestimating. Based on FDA recall #Z-0205-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0205-2026%22&limit=1).
The FDA announced on Sept. 12, 2025, that Diagnostica Stago, Inc. is recalling STA Liatest D-Di (REF: 00515) due to a potential risk of underestimating D-Dimer levels. The recall affects lots 271382 and 271411 distributed worldwide.
How to tell if you have it
Brand: Diagnostica Stago
Product: STA Liatest D-Di
REF: 00515
Lot numbers: 271382, 271411
Expiration date: 09/30/2025
The hazard
According to the FDA, the recalled product poses a potential risk of underestimation of D-Dimer levels. The agency classified this as a Class II recall.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since Oct. 25, 2017. Other recent recalls of similar products include GET TESTED D-Dimer Test Recall (Nov. 3, 2025), Immunotech Estrone RIA Kit Recall (Dec. 15, 2025), and Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026).
How to tell if you have this one
Check the lot numbers on your STA Liatest D-Di kit: 271382 or 271411. These kits were sold with expiration date 09/30/2025.
Brand
Diagnostica Stago
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Look for lot numbers 271382 or 271411 on your STA Liatest D-Di kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution- US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0205-2026 (September 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0205-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.