FDA-Device2025-10-22Class II
Product: STA Liatest D-Di; REF: 00515;
Hazard
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Sold states
Worldwide distribution- US Nationwide and the country of Canada.
Affected count
12740 units
Manufactured in
5 Century Dr, Parsippany, NJ, United States
Products
Product: STA Liatest D-Di; REF: 00515;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2026More Diagnostica Stago, Inc. recalls
- FDA-Device2026-09-09Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
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