The Recall Desk
SevereFDA (Devices)·Z-0480-2022·Announced 2022-02-09

COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval

CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.

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 classified this as a Class I recall, which per the rubric guidelines requires a minimum score of Severe (4). The unauthorized distribution of a medical diagnostic device without FDA marketing approval or authorization represents a serious regulatory violation. No illnesses or injuries are reported in the source text.

Plain-English summary

CovClear COVID-19 Rapid Antigen Test (ATG 900-031), manufactured by Empowered Diagnostics LLC, was offered for sale and distributed to consumers across the United States without FDA marketing approval, clearance, or authorization. A total of 284,575 units were distributed nationwide, affecting all lots of the product.

The FDA Class I recall was issued because these test kits were distributed without the required FDA authorization.

If you have purchased this product, do not use it. Contact Empowered Diagnostics LLC or the retailer where you purchased the test for further information and guidance.

The recalled product

Product
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Manufacturer
Empowered Diagnostics LLC
Category
Medical Device — COVID-19 Diagnostic Test
Hazard
  • unauthorized-medical-device

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)

  • All lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category