FDA recall Z-0564-2022

Product

E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

Reason for recall

The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

Distribution

US Nationwide distribution in the states of MA, FL, and HI.

Key facts

Status

Terminated

Initiation date

2022-01-27

Report date

2022-02-16

Termination date

2022-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2022