E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Reported: February 16, 2022 Initiated: January 27, 2022 #Z-0564-2022
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.
Details
- Recalling Firm
- E25Bio, Inc.
- Units Affected
- 73,300 units
- Distribution
- US Nationwide distribution in the states of MA, FL, and HI.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit. Recalled by E25Bio, Inc.. Units affected: 73,300 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Critical. Recall number: Z-0564-2022.
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