Chembio Diagnostics recalls DPP Micro Reader for COVID-19 antibody testing due to FDA revocation of emergency use authorization. Affected units have model 70-1069-0 and specific lot numbers. Stop using immediately to avoid inaccurate test results.
FDA revocation of the Emergency Use Authorization due to performance issues
Chembio Diagnostics is recalling its DPP Micro Reader device for COVID-19 antibody testing because the FDA revoked its emergency use authorization due to performance issues. This means the device may not work correctly, leading to inaccurate test results.
The FDA revoked the emergency use authorization because the device has performance issues that could lead to inaccurate test results. This means the device may not correctly detect antibodies to SARS-CoV-2, potentially causing false negatives or positives.
People who own or use the Chembio DPP Micro Reader for COVID-19 antibody testing are affected. Those who have the specific model number 70-1069-0 and the listed lot numbers are most at risk.
Check for the model number 70-1069-0 on the device. The affected units have lot numbers 83716171, 83720151, or 83720153.
The device has been recalled due to FDA revocation of emergency use authorization, so stop using it now to avoid inaccurate test results.
The FDA revoked the emergency use authorization because the device has performance issues that could lead to inaccurate test results.
The affected model number is 70-1069-0 with lot numbers 83716171, 83720151, and 83720153.
The recall record does not specify a return process, so contact Chembio Diagnostics directly for instructions.
We’ve drafted a message you can send Chembio to request your refund or repair — edit it as you like.
Subject: Recall Z-2808-2020 — Chembio Chembio Hello, I own a Chembio that is covered by recall Z-2808-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
