# FDA recall Z-0716-2022

> **Lusys Laboratories, Inc.** · Class I · device recall initiated 2022-01-13.

## Product

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

## Reason for recall

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico.  Pending additional information for a complete Consignee Listing

## Key facts

- **Recall number:** Z-0716-2022
- **Recalling firm:** Lusys Laboratories, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-13
- **Report date:** 2022-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2022

## Citation

> AI Analytics. FDA recall Z-0716-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0716-2022. Source: US FDA. Licensed CC0.

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