Guilford, CT, United States
Detect Headquarters recalls
1 recall recorded since 2018, most recently on 8 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 December 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0879-2023
- Detect Covid-19 Test Product/Model Number: 21205
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.