# FDA recall Z-1539-2021

> **INNOVA MEDICAL GROUP, INC.** · Class I · device recall initiated 2021-04-09.

## Product

COVID-19 Self-Test Kit *** INNOVA *** 3T

## Reason for recall

Due to distributing test kits to customers who were not part of a clinical investigation.

## Distribution

Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

## Key facts

- **Recall number:** Z-1539-2021
- **Recalling firm:** INNOVA MEDICAL GROUP, INC.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-09
- **Report date:** 2021-06-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2021

## Citation

> AI Analytics. FDA recall Z-1539-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1539-2021. Source: US FDA. Licensed CC0.

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