FDA Medical Device Recalls (openFDA)
E25Bio, Inc.: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
- Recall number
- Z-0564-2022
- Recalling firm
- E25Bio, Inc.
- Product
- E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
- Status
- Terminated
- Initiated
- 2022-01-27
- Posted
- 2022-02-09
- Terminated
- 2022-09-19
- 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.
- 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 info@e25bio.com 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 info@e25bio.com or recall@e25bio.com. 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 info@e25bio.com.
- Quantity
- 73,300 units
- Distribution
- US Nationwide distribution in the states of MA, FL, and HI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3016639746
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28