The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1539-2021·Announced 2021-06-16

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.

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 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

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.

The notice also names 34 states specifically:

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.

See all →

Same hazard · unvalidated product

See all →

Similar recalls