# FDA recall Z-1620-2021

> **LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD** · Class I · device recall initiated 2021-04-26.

## 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

- **Recall number:** Z-1620-2021
- **Recalling firm:** LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-04-26
- **Report date:** 2021-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beijing, China

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1620-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1620-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*