FDA recall Z-2807-2020

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

Reason for recall

FDA revocation of the Emergency Use Authorization due to performance issues

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-06-18

Report date

2020-08-26

Termination date

2021-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medford, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2807-2020