LumiraDx recalls SARS-CoV-2 Antibody Test Strips with unapproved modifications that could affect results. Affected lots expire by August 2022. No remedy specified.
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
LumiraDx is recalling SARS-CoV-2 Antibody Test Strips that were modified outside approved EUA guidelines. This could lead to inaccurate test results if used as intended.
The test strips were modified without following the approved EUA guidelines. This could cause inaccurate antibody test results, potentially leading to incorrect health decisions.
People who purchased or use LumiraDx SARS-CoV-2 Antibody Test Strips with the listed lot numbers. Those testing for COVID-19 antibodies may be at risk of inaccurate results.
Check the lot number on the test strip packaging. Affected lots include 5000599 (expiring 08-Mar-2022), 5000602 (expiring 10-Mar-2022), and others listed in the recall notice.
Look for the lot number on the test strip packaging to determine if it is affected.
The test strips were modified outside the scope of the approved EUA, which could affect test accuracy.
The recall notice does not specify a remedy, so check the lot number to see if it is affected.
The recall indicates a risk of inaccurate results, not physical harm. No immediate safety hazard is described.
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1450-2022 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-1450-2022 from LumiraDx. 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.
