Recall Z-0564-2022— E25Bio, Inc.
Class I · Terminated
Class I FDA medical device recall by E25Bio, Inc., initiated 2022-01-27, terminated 2022-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit. 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..
- Recalling firm
- E25Bio, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-01-27
- Terminated
- 2022-09-19
- Firm location
- Cambridge, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.