# FDA recall Z-2807-2020

> **Chembio Diagnostics, Inc** · Class II · device recall initiated 2020-06-18.

## 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 heparin or EDTA. Model Number: 65-9569-0

## Reason for recall

FDA revocation of the Emergency Use Authorization due to performance issues

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2807-2020
- **Recalling firm:** Chembio Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-18
- **Report date:** 2020-08-26
- **Termination date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Medford, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2807-2020

## Citation

> AI Analytics. FDA recall Z-2807-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2807-2020. Source: US FDA. Licensed CC0.

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