Device recall
Z-2809-2020: Chembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid…
FDA device recall · Class II · Chembio Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-2809-2020 |
|---|---|
| Recall event | 86098 |
| 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… |
| Product code | QKO |
| Recalling firm | Chembio Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2021 |
| FEI number | 2431980 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database