Detect Covid-19 Test Product/Model Number: 21205
FDA Recall #Z-0879-2023 — Class II — December 8, 2022
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.
Recalling Firm
Detect Headquarters — Guilford, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10142 (US); 960 OUS
Distribution
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Code Information
HY263, HY264, and HB264 Expiration 01JAN2023
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated