# FDA recall Z-0564-2022

> **E25Bio, Inc.** · Class I · device recall initiated 2022-01-27.

## 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

- **Recall number:** Z-0564-2022
- **Recalling firm:** E25Bio, Inc.
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0564-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0564-2022. Source: US FDA. Licensed CC0.

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