Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chembio DPP¿ Micro Reader II for use with the DPP¿ Recalled by Chembio Diagnostics, Inc Due to FDA revocation of the Emergency Use Authorization due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Chembio Diagnostics, Inc directly.
Affected Products
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
Quantity: 97 kits
Why Was This Recalled?
FDA revocation of the Emergency Use Authorization due to performance issues
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Chembio Diagnostics, Inc
Chembio Diagnostics, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report