Device recall

Z-1696-2023: Alinity i Anti-TPO Reagent Kit, List Number 09P3521

FDA device recall · Class III · Abbott Ireland Limited

Key facts

Recall number (Z-number) Z-1696-2023
Recall event 92271
Product Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Product code JZO
Recalling firm Abbott Ireland Limited
Recall class Class III
Status Open, Classified
510(k) numbers K052407
FEI number 3008344661

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)