Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- Diagnostica Stago
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Diagnostica Stago
- Product type
- D-Dimer immunoassay kit
- Model numbers
- REF: 00515, UDI-DI: 03607450005158, Lot numbers: 271382, 271411, Expiration 09/30/2025
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
D-Dimer immunoassays are used in clinical laboratories to help assess thrombotic risk in patients. The STA Liatest D-Di kit is part of this testing family. The recall concerns two lots with potential underestimation risk.
Why This Is Dangerous
If D-Dimer levels are underestimated, clinicians may misinterpret results, potentially delaying diagnosis and treatment of blood clots.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and labs using affected lots may need to retest patient samples if results were impacted. The issue could affect diagnostic decisions and patient safety.
Practical Guidance
How to identify if yours is affected
- Check lot numbers 271382 or 271411
- Confirm expiration date 2025-09-30
- If affected, stop using the kit immediately
Where to find product info
FDA recall page referenced in the notice; manufacturer instructions also apply
What timeline to expect
Timelines for refunds or replacements are not specified in the notice; contact Diagnostica Stago for details
If the manufacturer is unresponsive
- Document all communications with Diagnostica Stago
- If the company is unresponsive, file a report with the FDA recall process or seek guidance from your institution's risk department
How to prevent similar issues
- Verify lot numbers and expiration date before use in any lot of D-Dimer testing kits
- Maintain a strict recall check workflow for all laboratory reagents
- Consider alternative D-Dimer testing platforms from other manufacturers if needed
- Regularly review FDA recall notices and vendor alerts
Documentation advice
Keep the recall notice, verify lot numbers, retain all packaging and labeling, photograph lot/expiry codes, document testing impact and communications with the manufacturer
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Product Details
Brand: Diagnostica Stago Product: STA Liatest D-Di Reference: REF 00515 UDI-DI: 03607450005158 Lot numbers: 271382, 271411 Expiration: 2025-09-30 Quantity: 12,740 units Sold worldwide, including US nationwide and Canada Recall status: ACTIVE Recall date: 2025-09-12 Report date: 2025-10-22
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot numbers 271382 and 271411
- Worldwide distribution (US nationwide and Canada)
- Stop use immediately; follow recall instructions
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Safety Guide
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