Detect Covid-19 Test Product/Model Number: 21205 — Class II medical device recall Z-0879-2023
Ongoing recall by Detect Headquarters, reported 2023-01-11, distributed nationwide. There is an increased chance that the tests from affected lots may give false negative results. Health risks r
| Recall number | Z-0879-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Detect Headquarters, Guilford, CT, United States |
| Recall initiated | 2022-12-08 |
| Classified | 2023-01-04 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Model numbers | 21205 |
| Expiration dates | 2023-01-01 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0879-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.