Device recall

Z-1585-2026: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog…

FDA device recall · Class II · Diagnostica Stago, Inc.

Key facts

Recall number (Z-number) Z-1585-2026
Recall event 98362
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…
Product code DAP
Recalling firm Diagnostica Stago, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K162227
FEI number 2245451

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)