Abbott Diagnostics Scarborough, Inc. recalls 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

Recalled April 23, 2025 · FDA recall Z-1571-2025 · Abbott Diagnostics Scarborough

Hazard

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. · FDA Class II

Units

339456 eaches (337560 US, 1896 OUS)

Sold at

Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.

Description

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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

Manufacturer(s)

Abbott Diagnostics Scarborough, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →