Recall Z-0879-2023— Detect Headquarters
Class II · Ongoing
Class II FDA medical device recall by Detect Headquarters, initiated 2022-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Detect Covid-19 Test Product/Model Number: 21205. 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..
- Recalling firm
- Detect Headquarters
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-08
- Firm location
- Guilford, CT, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.