Recall Z-1620-2021— LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Class I · Completed
Class I FDA medical device recall by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD, initiated 2021-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S..
- Recalling firm
- LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- Classification
- Class I
- Status
- Completed
- Initiated
- 2021-04-26
- Firm location
- Beijing, China
Product description
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).
Reason for recall
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Data sourced from openFDA. This site is unofficial and independent of the FDA.