Device recall

Z-1571-2025: Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T…

FDA device recall · Class II · Abbott Diagnostics Scarborough, Inc.

Key facts

Recall number (Z-number) Z-1571-2025
Recall event 96519
Product Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Product code QWR
Recalling firm Abbott Diagnostics Scarborough, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K221925
FEI number 1221359

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)