medical Class II Updated 2022-07-27

LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

Recalled Product

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control


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. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
View official government recall

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