FDA Device recall Z-0481-2022
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
- FDA Device
- Class I
- completed
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class I recall of ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 by Empowered Diagnostics, citing COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0481-2022 |
| Classification | Class I |
| Status | completed |
| Initiated | 2021-12-22 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Empowered Diagnostics |
| Distribution | US |
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Reason
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0481-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.