Recall archive / FDA device enforcement
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit — FDA record Z-0564-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- E25Bio, Inc.
- Quantity
- 73,300 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0564-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of MA, FL, and HI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 16, 2022
- Recall initiation date
- Jan 27, 2022
- Center classification date
- Feb 9, 2022
- Termination date
- Sep 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.