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Posted April 23, 2021

FDA Warns 5 Sellers of Unapproved COVID-19 Tests

Between March 18 and April 6, 2021, the FDA issued warning letters to five companies for selling unapproved, adulterated, and misbranded tests for coronavirus (COVID-19). The products are QUIKPACII COVID-19 ANTIBODY TEST KIT and Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold) from Block Scientific; COVID-19 IgM/IgG Rapid Test from TM Technologies, Inc./TM Labs; Akcutest COVID-19 Antibody Test and Lumigenik COVID-19 Antigen Rapid Test from Ikcon Medical; At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests), COVID-19 Antibodies Test Kit, SKY Medical Supplies & Equipments, LLC Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 RAPID TEST DEVICE Whole Blood/Serum/Plasma, and Xiamen Wiz Biotech CO., LTD SARS-CoV-2 Antigen Rapid Test Test Device from Fast Masks USA LLC; and Rapid COVID-19 Antibody Self Test Kit and Rapid COVID-19 Antigen Self Test Kit from Sethi Laboratories.

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