Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di

Recalling company

Diagnostica Stago, Inc.

Product

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.

Reason

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 5, 2026

Reported

Mar 25, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.

Status

Ongoing

Quantity

34000 units (28446 US, 5554 OUS)

Lot / codes

Model/Catalog Number: REF 00515; UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515; Lot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219;

Company location

Parsippany, NJ

Recall type

Voluntary: Firm initiated

Recall number

Z-1585-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1585-2026 in the FDA Enforcement Report. Also see FDA recall press releases.