# FDA recall Z-0481-2022

> **Empowered Diagnostics LLC** · Class I · device recall initiated 2021-12-22.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0481-2022
- **Recalling firm:** Empowered Diagnostics LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-12-22
- **Report date:** 2022-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pompano Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2022

## Citation

> AI Analytics. FDA recall Z-0481-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0481-2022. Source: US FDA. Licensed CC0.

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