FDA recall Z-0879-2023

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

Status

Ongoing

Initiation date

2022-12-08

Report date

2023-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guilford, CT, United States

Primary source

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