Lower riskMedical device recall · FDA · Published January 27, 2022
E25Bio COVID-19 Rapid Test Recall: Not FDA Approved for Clinical Use
E25Bio recalls its COVID-19 Direct Antigen Rapid Test kits as they were distributed without FDA authorization for clinical use. Consumers should not use these products for testing.
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.
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Contact the company
📍Recalling firmE25Bio, Inc.501 Massachusetts Ave, The Engine · Cambridge, MA 02139-4018
✎ GovInfoNow plain-language explainer
E25Bio is recalling its COVID-19 Direct Antigen Rapid Test kits because they were distributed without proper FDA authorization for clinical or screening purposes. This means the tests may not work correctly and could give inaccurate results. Read more at govinfonow.com/recall/61214-e25bio-covid-19-rapid-test-recall-not-fda-approved-for.
“E25Bio COVID-19 Rapid Test Recall: Not FDA Approved for Clinical Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61214-e25bio-covid-19-rapid-test-recall-not-fda-approved-for. Based on FDA recall #Z-0564-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0564-2022%22&limit=1).
The FDA announced on Jan. 27, 2022, that E25Bio, Inc. is recalling its E25Bio COVID-19 Direct Antigen Rapid Test and E25Bio COVID-19 DART Kit because the devices were distributed without sufficient directions or controls in place. The agency stated the tests were not authorized, cleared, or approved for clinical diagnostic or screening purposes.
Distribution: US Nationwide, including MA, FL, and HI
Units: 73,300
The hazard
According to the FDA, the E25Bio COVID-19 Direct Antigen Rapid Test and E25Bio COVID-19 DART Kit were not authorized, cleared, or approved for clinical diagnostic or screening purposes. The record states they were distributed without sufficient directions or controls in place.
Context
GovInfoNow's records show the brand has been involved in other recent recalls of similar products, including the GET TESTED D-Dimer Test Recall on Nov. 3, 2025, and the Bisaf Strep A Self-Test Recall on Dec. 19, 2025. Other recent recalls of similar products include the DFI One Step 10A In Vitro Diagnostic Test Recall (April 2, 2026).
How to tell if you have this one
Check for the E25Bio brand and product names 'COVID-19 Direct Antigen Rapid Test' or 'DART Kit'. The affected units were purchased between October 13, 2020, and November 27, 2021, based on the purchase orders listed.
Brand
E25Bio
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the E25Bio brand and product names 'COVID-19 Direct Antigen Rapid Test' or 'DART Kit' on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MA, FL, and HI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Hawaii, Massachusetts.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0564-2022 (January 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0564-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.