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LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Recalled July 27, 2022 · FDA recall Z-1450-2022 · LumiraDx
Hazard
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. · FDA Class II
Units
635 units
Sold at
Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Description
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Manufacturer(s)
LumiraDx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →