FDA Device recall Z-0564-2022
E25Bio COVID-19 Direct Antigen Rapid Test
- FDA Device
- Class I
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class I recall of E25Bio COVID-19 Direct Antigen Rapid Test by E25bio, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0564-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-27 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | E25bio |
| Distribution | US |
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.
Identifiers
| code_info | Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0564-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.