LEPU's SARS-CoV-2 antibody test kit is not approved for U.S. sale. This recall covers all units distributed in the U.S. due to lack of FDA authorization.
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
LEPU's SARS-CoV-2 antibody rapid test kit is being recalled because it has not been approved by the U.S. FDA for use in the United States. This means the product is not legally available for sale or use here.
The test kit has not been authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) for marketing or distribution in the United States. This means it does not meet U.S. safety and quality standards for medical devices.
Anyone who purchased this test kit from a U.S. distributor. The risk is low since the product isn't approved for U.S. use, but users should avoid using it.
This product is labeled as 'Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD' and was distributed in the U.S. All units are affected.
Look for the product name and model number on the label to confirm it matches the recalled item.
The U.S. FDA has not approved this test kit for use in the United States, so it is not safe for medical purposes here.
The product has not been authorized, cleared, or approved by the U.S. FDA for marketing or distribution in the United States.
Yes, because it is not approved for U.S. use and could pose risks if used incorrectly.
We’ve drafted a message you can send LEPU to request your refund or repair — edit it as you like.
Subject: Recall Z-1619-2021 — LEPU LEPU Hello, I own a LEPU that is covered by recall Z-1619-2021 from LEPU. 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.
