Detect Covid-19 Test Product/Model Number: 21205
Reported: January 11, 2023 Initiated: December 8, 2022 #Z-0879-2023
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.
Details
- Recalling Firm
- Detect Headquarters
- Units Affected
- 10142 (US); 960 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Hong Kong.
- Location
- Guilford, CT
Frequently Asked Questions
What product was recalled? ▼
Detect Covid-19 Test Product/Model Number: 21205. Recalled by Detect Headquarters. Units affected: 10142 (US); 960 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0879-2023.
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