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Chembio Diagnostics, Inc recalls Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation
Recalled August 26, 2020 · FDA recall Z-2807-2020 · Chembio Diagnostics
Hazard
FDA revocation of the Emergency Use Authorization due to performance issues · FDA Class II
Units
7,674 kits (153,480 devices)
Sold at
Nationwide
Description
FDA revocation of the Emergency Use Authorization due to performance issues
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
Manufacturer(s)
Chembio Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →