FDA recall Z-1574-2025

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

US Nationwide distribution.

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-1574-2025