FDA-Device2025-04-23Class II
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
Abbott Diagnostics Scarborough, Inc.
Hazard
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Sold states
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.
Affected count
339456 eaches (337560 US, 1896 OUS)
Manufactured in
10 Southgate Rd, Scarborough, ME, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1571-2025Don't want to check this manually?
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