Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: Recalled by LumiraDx Due to Assigned vial lot numbers for the incorrect type...
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 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
Quantity: 83 kits
Why Was This Recalled?
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
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