Chembio Diagnostics, Inc recalls Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qu…

Recall date

June 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2809-2020

FDA classification

Class II

Brand / firm

Chembio Diagnostics, Inc

Sold / distributed

Nationwide

Why it was recalled

FDA revocation of the Emergency Use Authorization due to performance issues

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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