Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests Recalled by LumiraDx Due to Observations of potential false positive results in the...
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
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Quantity: 3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, GA, PA, SD
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