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Chembio Diagnostics, Inc recalls Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qua
Recalled August 26, 2020 · FDA recall Z-2809-2020 · Chembio Diagnostics
Hazard
FDA revocation of the Emergency Use Authorization due to performance issues · FDA Class II
Units
97 kits
Sold at
Nationwide
Description
FDA revocation of the Emergency Use Authorization due to performance issues
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
Manufacturer(s)
Chembio Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →