FDA Device recall Z-2809-2020
Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection…
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection… by Chembio Diagnostics, citing FDA revocation of the Emergency Use Authorization due to performance issues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2809-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-18 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Chembio Diagnostics |
| Distribution | US |
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
FDA revocation of the Emergency Use Authorization due to performance issues
Identifiers
| code_info | Lot Numbers: 96820051 96820052 96820181 96820191 96820201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2809-2020%22
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