Chembio Diagnostics, Inc recalls Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19
Recalled 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
Hazard / Issue
FDA revocation of the Emergency Use Authorization due to performance issues
Issued by
FDA
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