Device recall

Z-0958-2023: Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems…

FDA device recall · Class III · Abbott Laboratories

Key facts

Recall number (Z-number) Z-0958-2023
Recall event 91303
Product Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Product code DHA
Recalling firm Abbott Laboratories
Recall class Class III
Status Open, Classified
510(k) numbers K170317
FEI number 3016438761

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)