FDA recall Z-1571-2025

Abbott Diagnostics Scarborough, Inc. · Class II · device

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

Reason for recall

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

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2025-03-04
Report date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Scarborough, ME, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1571-2025