Chembio Diagnostics, Inc: Medical Device Recall in 2020 - (Recall #: Z-2807-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 18, 2020

Date Posted: August 26, 2020

Recall Number: Z-2807-2020

Event ID: 86098

Reason for Recall:

FDA revocation of the Emergency Use Authorization due to performance issues

Status: Terminated

Product Quantity: 7,674 kits (153,480 devices)

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated