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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

STA Liatest D-Di Recalled for Potential Underestimation of D-Dimer Levels

Agency Publication Date: October 16, 2025
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Summary

Diagnostica Stago, Inc. has recalled 12,740 units of STA Liatest D-Di diagnostic kits due to a potential risk that the test may underestimate D-Dimer levels in patient samples. This product is a laboratory test used to help detect and monitor blood clotting disorders. The recall affects two specific lots of the product with an expiration date of September 30, 2025.

Risk

Underestimating D-Dimer levels can lead to a false-negative result, which may cause a healthcare provider to miss a diagnosis of a serious blood clot, such as deep vein thrombosis or a pulmonary embolism. This could delay critical medical treatment for life-threatening conditions.

What You Should Do

  1. This recall involves STA Liatest D-Di (REF: 00515) diagnostic kits with lot numbers 271382 and 271411 and an expiration date of 09/30/2025.
  2. Stop using the recalled product immediately.
  3. Contact Diagnostica Stago, Inc. or your laboratory distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: STA Liatest D-Di
Model / REF:
00515
Lot Numbers:
271382 (Exp 09/30/2025)
271411 (Exp 09/30/2025)
UDI:
03607450005158

Recall Number: Z-0205-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97596
Status: Active
Manufacturer: Diagnostica Stago, Inc.
Manufactured In: United States
Units Affected: 12740 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.