Home / Recalls / Chembio Diagnostics, Inc / Z-2807-2020

Z-2807-2020 Class II Terminated

Recalled by Chembio Diagnostics, Inc — Medford, NY

Recall Details

Product Type: Devices
Report Date: August 26, 2020
Initiation Date: June 18, 2020
Termination Date: August 11, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,674 kits (153,480 devices)

Product Description

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 Pattern

Nationwide

Code Information

Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120