Product: STA Liatest D-Di recallZ-0205-2026 · Diagnostica Stago, Inc. · initiated Sep 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
FDA root cause category: Under Investigation by firm
What the company is doing
On September 12, 2025 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were emailed to customers. Actions for customers: Discontinue use of affected lots and dispose of them in accordance with your local regulations. Complete and return response form. For additional information, please contact Stago's 24/7 Hotline at 1-800-725-0607.
Recall details
- Recall number
- Z-0205-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2025
- Posted by the FDA
- Oct 16, 2025
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 12740 units
- Product code
- DAP
- FDA submissions
- K141144, K162227, K964728
- Distribution
- Worldwide distribution- US Nationwide and the country of Canada.
Product description
Product: STA Liatest D-Di; REF: 00515;
Code information (models, lots, serial numbers)
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STA® - Liatest® D-Di 00515Diagnostica Stago · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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