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Z-0205-2026Class II
Diagnostica Stago, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Diagnostica Stago, Inc.
Product type
Device
Status
Ongoing
Report date
2025-10-22
Distribution
Worldwide distribution- US Nationwide and the country of Canada.
Firm state
NJ
Product quantity
12740 units
Initiated by
Voluntary: Firm initiated
Reason for recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Product description
Product: STA Liatest D-Di; REF: 00515;
Code / lot info
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →