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.
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.
The tests were distributed without sufficient FDA authorization or clear instructions, meaning they may not be reliable for clinical or screening use. This could lead to incorrect results, which might affect health decisions.
Anyone who purchased the E25Bio COVID-19 Direct Antigen Rapid Test kits between October 2020 and November 2021 is affected. People using these tests for clinical purposes are at higher risk of inaccurate results.
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.
Look for the E25Bio brand and product names 'COVID-19 Direct Antigen Rapid Test' or 'DART Kit' on the packaging.
The recall states the tests were distributed without FDA authorization for clinical use, so they may not be reliable. Do not use them for testing.
Check for the E25Bio brand and product names 'COVID-19 Direct Antigen Rapid Test' or 'DART Kit'. Affected units were purchased between October 13, 2020, and November 27, 2021, based on the purchase orders listed.
The recall does not specify a remedy, so contact E25Bio directly for guidance on what to do with the product.
We’ve drafted a message you can send E25Bio to request your refund or repair — edit it as you like.
Subject: Recall Z-0564-2022 — E25Bio E25Bio Hello, I own a E25Bio that is covered by recall Z-0564-2022 from E25Bio. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
