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

Z-2809-2020 Class II Terminated

Recalled by Chembio Diagnostics, Inc — Medford, NY

FDA device recall Z-2809-2020 was initiated by Chembio Diagnostics, Inc on Jun 18, 2020 and is designated Class II. Reason for recall: FDA revocation of the Emergency Use Authorization due to performance issues The recall status is terminated (terminated Aug 11, 2021). Affected quantity: 97 kits.

Recall details

Product Type: Devices
Report Date: Aug 26, 2020
Initiation Date: Jun 18, 2020
Termination Date: Aug 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2809-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.