The Recall Desk
SevereFDA (Devices)·Z-1537-2021·Announced 2021-06-16

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.

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. 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.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • unauthorized-distribution

Distribution

Distributed nationwide across the United States.

Related recalls

Same category