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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
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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Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
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