FDA Device recall Z-2807-2020
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin…
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin… 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-2807-2020 |
| 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 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 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0
Reason
FDA revocation of the Emergency Use Authorization due to performance issues
Identifiers
| code_info | Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120 |
|---|
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-2807-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.