ImmunoPass — Class I medical device recall Z-0481-2022
Completed recall by Empowered Diagnostics LLC, reported 2022-02-09, distributed nationwide. COVID test kits were offered for sale and distributed to consumers in the United States without marketing appr
| Recall number | Z-0481-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Empowered Diagnostics LLC, Pompano Beach, FL, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 2,100 units |
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0481-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.