Z-2807-2020 Class II Terminated
FDA device recall Z-2807-2020 was initiated by Chembio Diagnostics, Inc on June 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 August 11, 2021). Affected quantity: 7,674 kits (153,480 devices).
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