Drug recall
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and…
FDA recall event 86098 · Class II · Chembio Diagnostics, Inc
Key facts
| Event ID | 86098 |
|---|---|
| Recall numbers | Z-2807-2020, Z-2808-2020, Z-2809-2020 |
| Recalling firm | Chembio Diagnostics, Inc |
| Product type | Devices |
| Products | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2…, Chembio DPP¿ Micro Reader 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | FDA revocation of the Emergency Use Authorization due to performance issues |
| Initiation date | Jun 18, 2020 |
| Report date | Aug 26, 2020 |
| Termination date | Aug 11, 2021 |
| City | Medford |
| State | NY |
| Country | United States |
| FEI number | 2431980 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: