# FDA recall Z-0183-2022

> **ELLUME LTD** · Class I · device recall initiated 2021-10-01.

## Product

Ellume COVID-19 Home Test

## Reason for recall

Due to a higher rate of false positive test results.

## Distribution

U.S.: MN, NY, PA, RI, UT, WA.    O.U.S.: Not provided

## Key facts

- **Recall number:** Z-0183-2022
- **Recalling firm:** ELLUME LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-01
- **Report date:** 2021-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brisbane, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2022

## Citation

> AI Analytics. FDA recall Z-0183-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0183-2022. Source: US FDA. Licensed CC0.

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