Product Wiki · Recalls · U.S. FDA — Device Enforcement

Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab). — recall Z-1620-2021

U.S. FDA — Device Enforcement · China · 2021-04-26 · Class I

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1620-2021
Date of alert
2021-04-26
Country / jurisdiction
China
Risk level
Class I
Risk type
recall
Brand
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Product category
device
Product type
Devices
Reported risk: Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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