Lusys Laboratories recalls unapproved COVID-19 antigen test kits sold in the U.S. due to lack of Emergency Use Authorization. These kits may not work correctly for detecting the virus.
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 second-generation COVID-19 viral antigen test kits because they are not approved for use in the U.S. This means the tests might not accurately detect the virus, potentially leading to incorrect results.
These test kits were not authorized by the FDA for use in the U.S. as of the recall date. Without proper approval, they may not detect the virus correctly, leading to false negatives or positives.
Anyone who purchased or used these unapproved test kits in the U.S. is affected. People most at risk are those who relied on the tests for accurate diagnosis.
Check for the product name 'LuSys 2nd Generation of COVID-19 Viral Antigen Test' with part number I-114(S) and all lot numbers. The kits were sold in the U.S. without an Emergency Use Authorization.
Look for the part number I-114(S) and all lot numbers on the test kit packaging.
The recall states these kits are not authorized for U.S. use, so they may not work correctly. They are not safe for accurate testing.
The recall does not specify a disposal step, so no action is required beyond checking if you have the product.
The tests lack FDA Emergency Use Authorization for U.S. distribution, meaning they were not approved for use in the U.S. as of the recall date.
We’ve drafted a message you can send Lusys to request your refund or repair — edit it as you like.
Subject: Recall Z-0716-2022 — Lusys Lusys Hello, I own a Lusys that is covered by recall Z-0716-2022 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.
