Device recall

Z-0461-2022: Alinity m System, Part No. 08N53-002

FDA device recall · Class II · Abbott Molecular, Inc.

Key facts

Recall number (Z-number) Z-0461-2022
Recall event 89167
Product Alinity m System, Part No. 08N53-002
Product code MZP
Recalling firm Abbott Molecular, Inc.
Recall class Class II
Status Open, Classified
FEI number 3005248192

At a glance

  • None 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)