LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

Recall date

June 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1450-2022

FDA classification

Class II

Brand / firm

LumiraDx

Sold / distributed

Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip