CovClear COVID-: FDA Unapproved Rapid Antigen Test Recall
Empowered Diagnostics recalls CovClear COVID-19 Rapid Antigen Test (ATG 900-031) sold without FDA approval. Consumers should not use unapproved tests.
Recall notice
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Contact the company
What happened, in plain English
Empowered Diagnostics is recalling all units of their CovClear COVID-19 Rapid Antigen Test (ATG 900-031) because it was sold without FDA approval. This means the test may not be safe or effective for use. Read more at govinfonow.com/recall/61402-covclear-covid-fda-unapproved-rapid-antigen-test-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/61402-covclear-covid-fda-unapproved-rapid-antigen-test-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0480-2022
Cite this page
“CovClear COVID-: FDA Unapproved Rapid Antigen Test Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61402-covclear-covid-fda-unapproved-rapid-antigen-test-recall. Based on FDA recall #Z-0480-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0480-2022%22&limit=1).
Why it’s dangerous
The test kits were distributed without FDA approval, meaning they haven't been tested for safety and effectiveness. Using unapproved tests could lead to incorrect results, which might cause unnecessary health concerns or missed diagnoses.
Who’s affected
Anyone who purchased the CovClear COVID-19 Rapid Antigen Test (ATG 900-031) from a retailer. People using unapproved tests could face inaccurate results or health risks.
How to tell if you have this one
Check for the product name 'CovClear COVID-19 Rapid Antigen Test' and model number ATG 900-031. All lots are affected, so every unit is recalled.
- Brand
Empowered Diagnostics- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Completed- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0480-2022 | CovClear COVID-19 Rapid Antigen Test, ATG 900-031; All lots | 284,575 units |
| Z-0481-2022 | ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60; all lots | 2100 units |
What to do — step by step
Stop Using It Now
Do not use the CovClear COVID-19 Rapid Antigen Test (ATG 900-031) as it was sold without FDA approval.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0480-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0480-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.