Lusys Laboratories recalls all I-111 COVID-19 antibody test kits sold in the U.S. due to lack of FDA authorization. These tests are not approved for use in the United States.
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 all I-111 COVID-19 antibody test kits sold in the U.S. because they are not authorized by the FDA for use in the country. Using these unapproved tests could lead to incorrect results and potential health risks.
These test kits were not approved by the FDA for use in the U.S. as of the recall date. Using unapproved tests could result in inaccurate results, which might lead to incorrect health decisions.
Anyone who purchased or uses Lusys Laboratories' I-111 COVID-19 antibody test kits in the U.S. may be affected. People most at risk are those who rely on these tests for medical diagnosis without proper authorization.
Check for the catalog number I-111 on the test kit packaging. The product was sold in the U.S. without an FDA Emergency Use Authorization (EUA).
Look for the catalog number I-111 on the test kit packaging to confirm it is part of the recall.
No, these tests are not approved by the FDA for use in the U.S. and may provide inaccurate results.
The recall record does not specify a remedy, so check the product details to confirm it is part of the recall and contact the manufacturer for further instructions.
The tests were not authorized, cleared, or approved by the FDA for marketing or distribution in the U.S. due to lack of Emergency Use Authorization (EUA).
We’ve drafted a message you can send Lusys Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0718-2022 — Lusys Laboratories Lusys Laboratories Hello, I own a Lusys Laboratories that is covered by recall Z-0718-2022 from Lusys Laboratories. 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.
