Chembio Diagnostics recalls its DPP COVID-19 IgM/IgG test system due to FDA revocation of emergency use authorization for performance issues. Affected units include specific model and lot numbers.
FDA revocation of the Emergency Use Authorization due to performance issues
Chembio Diagnostics is recalling its DPP COVID-19 IgM/IgG test system because the FDA revoked its emergency use authorization due to performance problems. This means the test may not work correctly for detecting coronavirus antibodies.
The FDA has revoked the emergency use authorization because the test system has performance issues. This means the test may not correctly detect coronavirus antibodies, leading to unreliable results.
People who own or use the Chembio DPP COVID-19 IgM/IgG test system with the specified model number and lot numbers are affected. Those who rely on this test for coronavirus antibody detection are at risk of inaccurate results.
Check for the model number 65-9569-0 and lot numbers CV041020/A, CV041520, CV040220/A1, CV042420, CV042920, or CV040320/A2, CV050120 on the test kit packaging.
Look for the model number 65-9569-0 and lot numbers listed above on the test kit packaging.
The FDA revoked the emergency use authorization due to performance issues with the test system.
Model number 65-9569-0 and lot numbers CV041020/A, CV041520, CV040220/A1, CV042420, CV042920, CV040320/A2, and CV050120.
The recall does not specify a stop-use instruction, so you can continue using it but results may be unreliable.
We’ve drafted a message you can send Chembio to request your refund or repair — edit it as you like.
Subject: Recall Z-2807-2020 — Chembio Chembio Hello, I own a Chembio that is covered by recall Z-2807-2020 from Chembio. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
