Pasadena, CA, United States
INNOVA MEDICAL GROUP, INC. recalls
1 recall recorded since 2018, most recently on 9 April 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 9 April 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1539-2021, Z-1538-2021, Z-1537-2021
- COVID-19 Self-Test Kit *** INNOVA *** 3T
- For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
- COVID-19 Self-Test Kit *** INNOVA *** 7T
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.