Chembio DPP Micro Reader Recalled for Performance Issues
Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The source cites performance issues leading to EUA revocation but does not report specific injuries or illnesses, fitting the Moderate severity criteria for low-risk or precautionary recalls without confirmed harm.
Plain-English summary
Chembio Diagnostics, Inc. is recalling 126 units of the DPP Micro Reader, a device used with the DPP COVID-19 IgM/IgG System for detecting antibodies to SARS-CoV-2. The recall involves specific lot numbers: 83716171, 83720151, and 83720153. The product was distributed nationwide.
The recall was initiated because the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for the device due to performance issues. The DPP Micro Reader is a rapid immunochromatographic test intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies in fingerstick whole blood, venous whole blood, serum, or plasma.
Users of the affected devices should stop using them and contact Chembio Diagnostics, Inc. for further instructions or a refund. The recall is limited to the 126 kits identified by the specific lot numbers listed above.
The recalled product
- Product
- Chembio DPP¿ Micro Reader 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
- Manufacturer
- Chembio Diagnostics, Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 126
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 83716171 83720151 83720153
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.
See all 3 products in this recall →Related recalls
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See all →- ModerateChembio DPP Micro Reader II Recalled for Performance Issues
FDA (Devices) · 2020-08-26
- HighChembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues
FDA (Devices) · 2020-08-26
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