# FDA recall Z-0879-2023

> **Detect Headquarters** · Class II · device recall initiated 2022-12-08.

## Product

Detect Covid-19 Test  Product/Model Number: 21205

## Reason for recall

There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

## Distribution

Domestic distribution nationwide. Foreign distribution to Hong Kong.

## Key facts

- **Recall number:** Z-0879-2023
- **Recalling firm:** Detect Headquarters
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-08
- **Report date:** 2023-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2023

## Citation

> AI Analytics. FDA recall Z-0879-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0879-2023. Source: US FDA. Licensed CC0.

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