[pending] Product: STA Liatest D-Di; REF: 00515;
Pending LLM rewrite. Source: FDA_DEVICE Z-0205-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
The recalled product
- Product
- Product: STA Liatest D-Di; REF: 00515;
- Manufacturer
- Diagnostica Stago, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF: 00515
- UDI-DI: 03607450005158
- Lot numbers: 271382
- 271411
- Expiration 09/30/2025
Distribution
Distributed nationwide across the United States.
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