COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization
Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.
What this means for you
Illness, injury, or structural failure has been reported. 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 per the rubric. Although no product defect or user injury is reported, the unauthorized distribution of an unvalidated medical device violates regulatory requirements.
Plain-English summary
Innova Medical Group, Inc. is recalling its COVID-19 Self-Test Kit (model 3T) due to improper distribution. The affected test kits were distributed to customers who were not part of an authorized clinical investigation, violating FDA regulations governing medical device distribution.
The recall involves 402 boxes containing 1,206 tests (lot numbers U2102003 and X2012310). The kits were distributed nationwide throughout the United States, as well as to Canada, India, and the United Kingdom.
Consumers who have obtained these test kits should not use them. For additional information or guidance, contact Innova Medical Group or the FDA. This is classified as an FDA Class I recall, the agency's most serious classification for medical devices.
The recalled product
- Product
- COVID-19 Self-Test Kit *** INNOVA *** 3T
- Manufacturer
- INNOVA MEDICAL GROUP, INC.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unvalidated-product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 3T Lot Numbers: U2102003 X2012310
Distribution
Distributed nationwide across the United States.
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