Stago STA Liatest D-Di: Positive bias in D-dimer measurements

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Contact the company & request your remedy

Recalling firmDiagnostica Stago, Inc.5 Century Dr, N/A · Parsippany, NJ 07054-4607

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Stago is recalling STA Liatest D-Di blood test kits with model REF 00515 because they may give falsely high D-dimer results. This could lead to incorrect diagnoses of blood clotting conditions.

Why it’s dangerous

The kit may produce falsely elevated D-dimer measurements across all test ranges. This could cause doctors to incorrectly diagnose blood clotting disorders when no clotting is present or vice versa.

Who’s affected

Healthcare professionals using the STA Liatest D-Di kit for blood tests. Patients receiving inaccurate results from this test may be at risk of misdiagnosis.

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
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.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to positive bias in D-dimer measurements, which could lead to inaccurate blood test results for clotting conditions.

What is the model number for this product?

The model number is REF 00515.

How can I check if I have the recalled product?

Check for model number REF 00515 on the kit and verify the lot numbers listed in the recall notice.

Take action

Contact Stago

We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1585-2026 — Stago Stago

Hello,

I own a Stago that is covered by recall Z-1585-2026 from Stago.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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.

Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in

Lower-risk recall