Device 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
Z-2807-2020
Product summary
- Event
- Event 86098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,674 kits (153,480 devices)
- Official record key
device-enforcement:Z-2807-2020
Official wording
Reason: FDA revocation of the Emergency Use Authorization due to performance issues
Code information: Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
FDA revocation of the Emergency Use Authorization due to performance issues