Reported Jun 16, 2021 · Ongoing

COVID-19 Self-Test Kit *** INNOVA *** 3T

Innova Medical Group, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: INNOVA MEDICAL GROUP, INC. · 800 E Colorado Blvd Ste 200 · Pasadena, CA · 91101-5401

Is this the product you have?

  • COVID-19 Self-Test Kit *** INNOVA *** 3T
Lot codes and dates
  • Catalog Number3T
  • Lot NumbersU2102003 X2012310
Amount recalled
402 boxes (=1,206 tests)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Stop using this product now

Due to distributing test kits to customers who were not part of a clinical investigation.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.