⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Diagnostica Stago, Inc.: Product: STA Liatest D-Di; REF: 00515;

Medical DevicesSource: FDA (device) · Date: 2025-10-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Diagnostica Stago, Inc.
Product
Product: STA Liatest D-Di; REF: 00515;
Reason / hazard
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution- US Nationwide and the country of Canada.
Recall initiated
2025-09-12
Code info
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Product quantity
12740 units
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
97596
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