COVID-19 Self-Test Kit *** INNOVA *** 3T
Reported: June 16, 2021 Initiated: April 9, 2021 #Z-1539-2021
Product Description
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.
Details
- Recalling Firm
- INNOVA MEDICAL GROUP, INC.
- Units Affected
- 402 boxes (=1,206 tests)
- 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.
- Location
- Pasadena, CA
Frequently Asked Questions
What product was recalled? ▼
COVID-19 Self-Test Kit *** INNOVA *** 3T. Recalled by INNOVA MEDICAL GROUP, INC.. Units affected: 402 boxes (=1,206 tests).
Why was this product recalled? ▼
Due to distributing test kits to customers who were not part of a clinical investigation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1539-2021.
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