medical Class II Updated 2022-07-27

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

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, WI
Lot/Code Info: No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).
View official government recall

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