Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Recalled by LumiraDx Due to Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test...

Date: June 24, 2022
Company: LumiraDx
Status: Terminated
Source: FDA (Device)

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 Antibody (Ab) Liquid Quality Control

Quantity: 99 units

Why Was This Recalled?

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

Where Was This Sold?

This product was distributed to 13 states: AR, CA, FL, MD, MA, NV, NJ, NY, NC, OK, TN, TX, WI

Affected (13 states)Not affected

About LumiraDx

LumiraDx has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report