Lower riskMedical device recall · FDA · Published February 5, 2026
Stago STA Liatest D-Di: Positive bias in D-dimer measurements
Stago recalls STA Liatest D-Di kits with REF 00515 due to potential positive bias in D-dimer measurements, which could lead to inaccurate blood test results.
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Take action
Contact the company
📍Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607
“Stago STA Liatest D-Di: Positive bias in D-dimer measurements.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50048-stago-sta-liatest-d-di-positive-bias-in-d-dimer. Based on FDA recall #Z-1585-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1585-2026%22&limit=1).
Diagnostica Stago, Inc. recalled STA Liatest D-Di in vitro diagnostic kits due to a positive bias in D-Dimer measurements, the FDA said on Feb. 5, 2026. The agency announced the Class II recall after investigations confirmed the issue throughout the entire analytical range.
Investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. The recall was initiated after receiving customer complaints.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since 2017-10-25. Other recent recalls of similar products include Diagnostica Stago STA Staclot Protein S Recall (2026-07-29), Stago STA Liatest Free Protein S (2026-02-04), and Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15). Other recent recalls of similar products include GET TESTED D-Dimer Test Recall (2025-11-03) and Immunotech Estrone RIA Kit Recall (2025-12-15).
How to tell if you have this one
Check for model number REF 00515 on the kit. The kit is sold with specific lot numbers listed in the recall notice. It is used with STA-R, STA Compact, or STA Satellite analyzers in labs.
Brand
Stago
Product
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Look for model number REF 00515 on the kit packaging or label.
Contact Manufacturer
Reach out to Diagnostica Stago, Inc. for further assistance with the recall.
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 countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.” 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 48 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-1585-2026 (February 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1585-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.