U.S. recall: LEPU's SARS-CoV-2 antigen rapid test kits are not approved for U.S. distribution. Consumers should not use these kits for clinical testing.
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
LEPU's SARS-CoV- 2 antigen rapid test kits are being recalled because they are not authorized for use in the U.S. This means they cannot be used for clinical testing here.
These test kits were not approved by the U.S. Food and Drug Administration for clinical use. Using them could lead to incorrect results, which might affect health decisions.
U.S. consumers who purchased these test kits for home use. People using them for clinical testing are at risk of inaccurate results.
The test kits are labeled as 'Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD' and were distributed in the U.S. All lots are affected.
Look for the product name and model number on the kit to confirm it matches the recalled items.
These kits are not approved for U.S. clinical use and should not be used for testing.
The U.S. Food and Drug Administration has not approved these test kits for clinical use in the United States.
No, these kits are not approved for use in the U.S. and should not be used for clinical testing.
Do not use it. The recall covers all lots distributed in the U.S., but there is no specific return or disposal instruction.
We’ve drafted a message you can send LEPU to request your refund or repair — edit it as you like.
Subject: Recall Z-1620-2021 — LEPU LEPU Hello, I own a LEPU that is covered by recall Z-1620-2021 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.
