FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution
Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The recall addresses unauthorized distribution outside an authorized clinical investigation protocol, a serious regulatory violation, even though no illnesses or injuries have been reported.
Plain-English summary
Innova Medical Group, Inc. is recalling 370 boxes (approximately 2,590 individual tests) of its COVID-19 Self-Test Kit model 7T. The recall was initiated because the tests were distributed to customers who were not enrolled in or authorized for the clinical investigation program for which the product was approved.
This is a Class I recall from the FDA, indicating a serious regulatory violation. The affected product was distributed nationwide across 33 U.S. states and the District of Columbia, as well as internationally to Canada, India, and the United Kingdom.
If you have obtained one of these test kits, do not use it. Contact Innova Medical Group for instructions on return or replacement. The affected lot numbers are U2101748, U2102001, U2102002, X2012711, and X2103792.
The recalled product
- Product
- COVID-19 Self-Test Kit *** INNOVA *** 7T
- Manufacturer
- INNOVA MEDICAL GROUP, INC.
Distribution
Part of a larger recall action
This product is one of 3 recalled by INNOVA MEDICAL GROUP, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · INNOVA MEDICAL GROUP, INC.
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FDA (Devices) · 2021-06-16
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FDA (Devices) · 2021-06-16
Same hazard · unauthorized distribution
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