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.
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 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
- Affected units
- 284,575
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.
Part of a larger recall action
This product is one of 2 recalled by Empowered Diagnostics LLC 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 2 products in this recall →Related recalls
Same manufacturer · Empowered Diagnostics LLC
See all →- SevereCOVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale
FDA (Devices) · 2022-02-09
Same hazard · unauthorized medical device
See all →- ModerateDVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization
FDA (Devices) · 2024-10-09
- HighDVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization
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- SevereUnauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval
FDA (Devices) · 2022-03-23
- SevereLuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
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