The Recall Desk
HighFDA (Devices)·Z-1585-2026·Announced 2026-03-25

[pending] Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ

Pending LLM rewrite. Source: FDA_DEVICE Z-1585-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on S
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • (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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category