CLASS I Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
CovClear Covid-19 Rapid Antigen Test, ATG recalled
Empowered Diagnostics is recalling CovClear Covid-19 Rapid Antigen Test, ATG 900-031, distributed nationwide in the US. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0480-2022
- FDA event ID
- 89315
- Recalling firm
- Empowered Diagnostics, Pompano Beach, FL
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 22 Dec 2021
- FDA classified
- 28 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Dec 2021 | Recall initiated by company | |
| 28 Jan 2022 | Classified by FDA | +37 days |
| 9 Feb 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Product as listed by the FDA
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is CovClear Covid-19 Rapid Antigen Test, ATG 900-031 recalled?
Yes. Empowered Diagnostics recalled CovClear Covid-19 Rapid Antigen Test, ATG 900-031 on 22 Dec 2021. The recall is Class I and its status is Completed. Recall number Z-0480-2022.
Why was it recalled?
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Which lots are affected?
All lots
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Empowered Diagnostics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | ImmunoPass , Covid-19 Neutralizing Antibody Test, NAB recalled | Empowered Diagnostics | Other | Nationwide |
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