COVID-19 Self-Test Kit *** INNOVA *** 3T recall
COVID-19 Self-Test Kit *** INNOVA *** 3T
Why was COVID-19 Self-Test Kit *** INNOVA *** 3T 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: 3T Lot Numbers: U2102003 X2012310
- Product
- COVID-19 Self-Test Kit *** INNOVA *** 3T
- Recalling firm
- INNOVA MEDICAL GROUP, INC.
- Quantity
- 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.
- Recall date
- June 16, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)