Home / Recalls / Chembio Diagnostics, Inc / Z-2809-2020

Z-2809-2020 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
97 kits

Product Description

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

Reason for Recall

FDA revocation of the Emergency Use Authorization due to performance issues

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 96820051 96820052 96820181 96820191 96820201

Other recalls by Chembio Diagnostics, Inc

  • Z-2807-2020 Class II — Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the q (June 18, 2020)
  • Z-2808-2020 Class II — Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid i (June 18, 2020)