The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1538-2021·Announced 2021-06-16

INNOVA SARS-CoV-2 Antigen Rapid Tests Recalled for Unauthorized Non-Clinical Distribution

INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.

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 recall classification requires a minimum severity score of 4 per rubric rules. Although the recall is for unauthorized distribution (a regulatory compliance violation), no illnesses, injuries, or deaths are reported in the source text, preventing a higher score despite the Class I classification.

Plain-English summary

INNOVA Medical Group, Inc. is recalling the '25T 888 SARS-CoV-2 Antigen' rapid qualitative test kits (REF BT1309). The recall involves 1,945 boxes containing approximately 48,625 individual tests distributed nationwide and internationally.

The FDA classified this as a Class I recall because the test kits were distributed to customers who were not enrolled in an authorized clinical investigation. The kits are labeled 'For In Vitro Diagnostic Use Only' and are designed for use under clinical supervision.

The affected test kits were distributed to 32 U.S. states as well as Canada, India, and the United Kingdom. Affected lot numbers include U2101750, U2101751, X2006004, X2008001, X2008010, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, and multiple additional lots from the X2011, X2012, and X2101 series (for the complete list, consult the FDA recall notice).

Consumers with affected test kits should discontinue use immediately. Contact INNOVA Medical Group, Inc. or the product's distributor for instructions on returning the kits or obtaining a replacement.

The recalled product

Product
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Manufacturer
INNOVA MEDICAL GROUP, INC.
Category
Medical Device — In Vitro Diagnostic Test
Hazard

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 →

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