Empowered Diagnostics recalls CovClear COVID-19 Rapid Antigen Test (ATG 900-031) sold without FDA approval. Consumers should not use unapproved tests.
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
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.
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.
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.
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.
Do not use the CovClear COVID-19 Rapid Antigen Test (ATG 900-031) as it was sold without FDA approval.
The official recall states the test was sold without FDA approval, so it may not be safe or effective.
Check for the product name 'CovClear COVID-19 Rapid Antigen Test' and model number ATG 900-031. All lots are affected.
The recall does not specify a return process, but you should stop using it immediately as it was sold without FDA approval.
We’ve drafted a message you can send Empowered Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0480-2022 — Empowered Diagnostics Empowered Diagnostics Hello, I own a Empowered Diagnostics that is covered by recall Z-0480-2022 from Empowered Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
