Detect COVID-19 Test may produce false negative results in affected lots
Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where the defect (false negative results) could lead to delayed treatment and community spread of COVID-19, but no illnesses or injuries have been reported. FDA Class II classification without reported hospitalizations places this in the High category per the rubric.
Plain-English summary
Detect Headquarters is recalling affected lots of the Detect COVID-19 Test (Model 21205). Tests from affected lots have an increased chance of producing false negative results, which means they may fail to detect COVID-19 infection when a person is actually infected.
Affected lots include HY263, HY264, and HB264 with expiration dates of January 1, 2023. A total of 10,142 units were distributed in the United States, with an additional 960 units distributed to Hong Kong.
A false negative result can lead to a delay or complete lack of supportive treatment for infected individuals. It can also prevent infected individuals and their close contacts from being monitored for symptoms, thereby increasing the risk of COVID-19 spreading within the community.
The recalled product
- Product
- Detect Covid-19 Test Product/Model Number: 21205
- Manufacturer
- Detect Headquarters
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative
- diagnostic-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- HY263
- HY264
- and HB264 Expiration 01JAN2023
Distribution
Distributed nationwide across the United States.
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