Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG… — Class II medical device recall Z-2809-2020
Terminated recall by Chembio Diagnostics, Inc, reported 2020-08-26, distributed nationwide. FDA revocation of the Emergency Use Authorization due to performance issues
| Recall number | Z-2809-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chembio Diagnostics, Inc, Medford, NY, United States |
| Recall initiated | 2020-06-18 |
| Classified | 2020-08-14 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2021-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 97 kits |
| Lot numbers | 96820051, 96820052, 96820181, 96820191, 96820201 |
| Model numbers | 70-1070-0 |
Product
Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0
Reason for recall
FDA revocation of the Emergency Use Authorization due to performance issues
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-2809-2020. 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.