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Recall Observatory FDA recall evidence

Device product

Detect Covid-19 Test Product/Model Number: 21205

Z-0879-2023

December 08, 2022

Class II

Product summary

Firm
Detect Headquarters
Event
Event 91300
Status
Ongoing
Classification
Class II
Quantity
10142 (US); 960 OUS
Official record key
device-enforcement:Z-0879-2023

Official wording

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.

Code information: HY263, HY264, and HB264 Expiration 01JAN2023

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.