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LumiraDx

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in recall (Z-1970-2023)LumiraDx2023-06-15
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) recall (Z-0135-2023)LumiraDx2022-10-26
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip recall (Z-1450-2022)LumiraDx2022-07-22
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control recall (Z-1451-2022)LumiraDx2022-07-22
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respir recall (Z-1132-2021)LumiraDx2021-02-17

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