E25Bio COVID-19 Direct Antigen Rapid Test — Class I medical device recall Z-0564-2022
Terminated recall by E25Bio, Inc., reported 2022-02-16, distributed nationwide. The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was
| Recall number | Z-0564-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | E25Bio, Inc., Cambridge, MA, United States |
| Recall initiated | 2022-01-27 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2022-09-19 |
| Distributed | Nationwide (US) |
| Quantity | 73,300 units |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0564-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.