The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2809-2020·Announced 2020-08-26

Chembio DPP Micro Reader II Recalled for Performance Issues

Chembio Diagnostics is recalling 97 DPP Micro Reader II kits because the FDA revoked their 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 2/5 (Moderate).

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 of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is related to performance issues rather than a direct physical danger like fire or shock.

Plain-English summary

Chembio Diagnostics, Inc. is recalling 97 kits of the DPP Micro Reader II, a device used with the DPP COVID-19 IgM/IgG System. The system is a rapid immunochromatographic test designed 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.

The recall is being conducted because the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for the device due to performance issues. The affected products were distributed nationwide. The specific lot numbers involved in this recall are 96820051, 96820052, 96820181, 96820191, and 96820201.

Consumers and healthcare providers who have these specific kits should stop using them and contact Chembio Diagnostics, Inc. for further instructions or a refund.

The recalled product

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…
Manufacturer
Chembio Diagnostics, Inc
Category
Medical Device — Diagnostic Test
Hazard
Affected units
97

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: 96820051 96820052 96820181 96820191 96820201

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 →

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