Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2807-2020 — 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 Numb

U.S. FDA — Device Enforcement · United States · 2020-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2807-2020
Date of alert: 2020-06-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Chembio Diagnostics, Inc
Product category: device
Product type: Devices

Reported risk: FDA revocation of the Emergency Use Authorization due to performance issues

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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