medical Class II Updated 2020-08-26

Chembio Diagnostics, Inc recalls Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatogr

Recalled 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


Hazard / Issue

FDA revocation of the Emergency Use Authorization due to performance issues

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120
View official government recall

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