COVID-19 Self-Test Kit *** INNOVA *** 7T recall
COVID-19 Self-Test Kit *** INNOVA *** 7T
Why was COVID-19 Self-Test Kit *** INNOVA *** 7T recalled?
Due to distributing test kits to customers who were not part of a clinical investigation.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792
- Product
- COVID-19 Self-Test Kit *** INNOVA *** 7T
- Recalling firm
- INNOVA MEDICAL GROUP, INC.
- Quantity
- 370 boxes (=2,590 individual 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.
- Recall date
- June 16, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)