---
title: "Ellume COVID-19 Home Test — FDA record Z-0183-2022 | Is It on Recall"
description: "Due to a higher rate of false positive test results."
url: https://isitonrecall.com/recall/fda-device-z-0183-2022-ellume-covid-19-home-test/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Ellume COVID-19 Home Test — FDA record Z-0183-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Ellume COVID-19 Home Test
- **Reason**: Due to a higher rate of false positive test results.
- **Classification**: Class I
- **Recalling firm**: ELLUME LTD
- **Quantity**: 427,994 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0183-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0183-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Nov 17, 2021
- **Recall initiation date**: Oct 1, 2021
- **Center classification date**: Nov 10, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0183-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ELLUME LTD records](https://isitonrecall.com/brand/ellume-ltd/)