Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues
Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), particularly when the hazard involves diagnostic performance issues that could lead to incorrect medical decisions.
Plain-English summary
Chembio Diagnostics, Inc. is recalling 7,674 kits (153,480 devices) of the Chembio DPP COVID-19 IgM/IgG System. The recall is being conducted because the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for the product due to performance issues.
The affected products are rapid immunochromatographic tests used for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2. The kits were distributed nationwide. The specific lot numbers involved are CV041020/A, CV041520, CV040220/A1, CV042420, CV042920, CV040320/A2, and CV050120.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected kits and contact Chembio Diagnostics for further instructions or a refund.
The recalled product
- Product
- 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…
- Manufacturer
- Chembio Diagnostics, Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Chembio Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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