Lusys recalls its 2nd Gen COVID-19 antigen test kits as they lack U.S. FDA authorization. These kits may not be reliable for detecting the virus in the U.S. market.
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Lusys Laboratories is recalling its Luscient Diagnostics 2nd Generation COVID-19 Viral Antigen Test kits because they are not authorized for use in the U.S. This means the tests could give inaccurate results and are unsafe to use without proper regulatory approval.
These tests lack U.S. FDA authorization, meaning they haven't been proven safe or effective for use in the U.S. This could lead to false negatives or positives, which might result in incorrect health decisions.
Anyone who purchased or uses these tests in the U.S. may be affected. People relying on these tests for accurate results without FDA approval are at risk of incorrect results.
Check for the product name 'Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test' and part number I-114(N). All lots are affected due to the lack of FDA authorization.
Look for the product name and part number I-114(N) on the test kit packaging.
No, these tests are not authorized for use in the U.S. by the FDA, so they may not be safe or effective.
The tests lack U.S. FDA authorization, meaning they haven't been proven safe or effective for use in the U.S. market.
The recall does not require stopping use immediately, but the tests are not approved for U.S. use, so they may not be reliable.
We’ve drafted a message you can send Lusys to request your refund or repair — edit it as you like.
Subject: Recall Z-0717-2022 — Lusys Lusys Hello, I own a Lusys that is covered by recall Z-0717-2022 from Lusys. 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.
