Recall Z-2809-2020— Chembio Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Chembio Diagnostics, Inc, initiated 2020-06-18, terminated 2021-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: FDA revocation of the Emergency Use Authorization due to performance issues.
- Recalling firm
- Chembio Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-18
- Terminated
- 2021-08-11
- Firm location
- Medford, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.