Cambridge, MA, United States
E25Bio, Inc. recalls
1 recall recorded since 2018, most recently on 27 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 27 January 2022
- Terminated
- 19 September 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0564-2022
- E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.