LumiraDx recalls specific lots of SARS-CoV-2 antigen test strips due to potential false positives, which could lead to unnecessary treatment or quarantine. Affected lots include 5000269, 5000280, 5000306, 5000323, 6000142, and 6000100.
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips that may produce false positive results. This could lead to unnecessary treatment or quarantine for people who test positive but are actually healthy.
The test strips in the recalled lots may show a positive result when there is no actual infection. This could cause unnecessary treatment or quarantine for individuals who are not infected, leading to potential health risks and resource strain.
Healthcare professionals and lab staff using the LumiraDx test strips for SARS-CoV-2 antigen testing. Those most at risk are users of the recalled lots who might receive false positive results.
Check the lot numbers on the test strips: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261), 5000323 (GM2000354), 6000142 (GM2000296), and 6000100 (GM2000322). The product is part of the LumiraDx Platform for professional use.
Look for the lot numbers 5000269, 5000280, 5000306, 5000323, 6000142, or 6000100 on the test strips.
Using the recalled lots may result in false positive results, which could lead to unnecessary treatment or quarantine.
Check the lot numbers on the test strips: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261), 5000323 (GM2000354), 6000142 (GM2000296), and 6000100 (GM2000322).
The recall does not require stopping use immediately; check the lot numbers to see if your strips are affected.
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1132-2021 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-1132-2021 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.
