Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coronavirus antigen detection test system - Product Usage: intended for Recalled by LumiraDx Due to Two lots of test strips failed QC testing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LumiraDx directly.
Affected Products
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
Quantity: 2186 devices
Why Was This Recalled?
Two lots of test strips failed QC testing using blank buffer due to false positives.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LumiraDx
LumiraDx has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report