Medical Device Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative det
Diagnostica Stago, Inc. · February 5, 2026
Reason for Recall
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Product Description
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
States Affected
NATIONWIDE
Quantity Affected
34000 units (28446 US, 5554 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1585-2026
Status: ongoing
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