Chembio Diagnostics recalls DPP Micro Reader II devices for COVID-19 antibody testing after FDA revoked emergency use authorization due to performance problems. 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 Micro Reader II device for use with COVID-19 antibody tests because the FDA revoked its emergency use authorization due to performance issues. This means the device may not work correctly for testing.
The FDA revoked the emergency use authorization because the device has performance issues that could lead to inaccurate test results. This means the device might not properly detect antibodies to SARS-CoV-2, potentially giving false negatives or positives.
People who own the Chembio DPP Micro Reader II device with model number 70-1070-0 and lot numbers 96820051-96820201 are affected. Those using the device for COVID-19 antibody testing are most at risk.
Check for model number 70-1070-0 and lot numbers 96820051, 96820052, 96820181, 96820191, or 96820201 on the device. The device is used with the DPP COVID-19 IgM/IgG System for rapid antibody testing.
Verify the model number (70-1070-0) and lot numbers (96820051-96820201) to confirm if your device is affected.
The FDA revoked the emergency use authorization due to performance issues with the device.
The recall record does not specify a remedy, so you should check with Chembio Diagnostics for further instructions.
The device is not safe for use as the FDA has revoked its emergency use authorization due to performance issues.
We’ve drafted a message you can send Chembio to request your refund or repair — edit it as you like.
Subject: Recall Z-2809-2020 — Chembio Chembio Hello, I own a Chembio that is covered by recall Z-2809-2020 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.
