Device 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
Z-2809-2020
Product summary
- Event
- Event 86098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 kits
- Official record key
device-enforcement:Z-2809-2020
Official wording
Reason: FDA revocation of the Emergency Use Authorization due to performance issues
Code information: Lot Numbers: 96820051 96820052 96820181 96820191 96820201
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
FDA revocation of the Emergency Use Authorization due to performance issues