Z-0564-2022Class I

E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

Name: Z-0564-2022 E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Creator: E25Bio, Inc.
Published: 2022-01-27
License: https://open.fda.gov/license/

E25Bio, Inc. / initiated 2022-01-27 / Terminated

FDA source

E25Bio, Inc. began a recall of E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit on 2022-01-27. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0564-2022
Classification: Class I
Status: Terminated
Initiated: 2022-01-27
Posted: 2022-02-09
Terminated: 2022-09-19
Recalling firm: E25Bio, Inc.
Product: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Product code: QKP Coronavirus Antigen Detection Test System.
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.
FDA root cause: No Marketing Application
Action: On January 27, 2022, the firm began sending customers Urgent Medical Device Recall letters. Customers were instructed to do the following: Immediately examine your inventory for the affected product and quarantine any that are identified Do not use the COVID-19 Direct Antigen Rapid Test to diagnose or screen any individuals for COVID-19 Destroy the tests by placing them in the trash; alternatively, contact [email protected] for assistance in removing these products from your inventory Complete and return the response form to the firm as soon as possible, indicating the number of destroyed tests and the date in which the destruction of the tests took place; you may email the completed form to [email protected] or [email protected]. Please complete the form even if you do not have affected product on hand. If any Tests were distributed to third parties for their own use or for further distribution, please notify the firm of that information and include their identities as part of your Return Response. The enclosed form includes a section for that information to be provided. If you have any questions or concerns regarding this notice, please contact us at [email protected].
Quantity in commerce: 73,300 units
Distribution: US Nationwide distribution in the states of MA, FL, and HI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0564-2022	Class I	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-09

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)