FDA recall Z-1620-2021

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 for recall

Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Distribution

Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, Peru and Hong Kong.

Key facts

Status

Completed

Initiation date

2021-04-26

Report date

2021-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beijing, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1620-2021