LumiraDx recalls SARS-CoV-2 Antibody tests with a quality control modification made outside approved EUA. Affected units have specific lot numbers and catalog codes.
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 tests that had a quality control modification made outside approved EUA. This could affect test accuracy and reliability.
The test was modified without following the approved EUA (Emergency Use Authorization) process. This could lead to inaccurate results, but does not pose a direct physical risk to users.
People who purchased or use LumiraDx SARS-CoV-2 Antibody tests with the specific lot numbers and catalog codes listed. Those most at risk are users relying on these tests for accurate results.
Check for the catalog number L017080109002 and lot number 2002201428 (expires Sept 1, 2022). No UDI codes are present on these units.
Look for the catalog number L017080109002 and lot number 2002201428 on the test kit.
The test had a quality control modification made outside the approved EUA process, which could affect accuracy.
Check the catalog number and lot number to see if you have an affected unit. No specific action is required beyond checking.
No, the recall is for potential inaccurate results, not physical harm.
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1451-2022 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-1451-2022 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.
