Z-0879-2023 Class II Ongoing
FDA device recall Z-0879-2023 was initiated by Detect Headquarters on December 8, 2022 and is designated Class II. 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 la… The recall status is ongoing. Affected quantity: 10142 (US); 960 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- December 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10142 (US); 960 OUS
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Code Information
HY263, HY264, and HB264 Expiration 01JAN2023