Product: STA Liatest D-Di; REF: 00515;
Reported: October 22, 2025 Initiated: September 12, 2025 #Z-0205-2026
Product Description
Product: STA Liatest D-Di; REF: 00515;
Reason for Recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Details
- Recalling Firm
- Diagnostica Stago, Inc.
- Units Affected
- 12740 units
- Distribution
- Worldwide distribution- US Nationwide and the country of Canada.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Product: STA Liatest D-Di; REF: 00515;. Recalled by Diagnostica Stago, Inc.. Units affected: 12740 units.
Why was this product recalled? ▼
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0205-2026.
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