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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted January 12, 2022
FDA Warns Consumers Not to Use LuSys Laboratories COVID Tests Due to False Results
Update: (03/09/22) On February 17, 2022, the FDA issued a warning letter to LuSys Laboratories, Inc. following an inspection of the firm’s medical device operations in which the agency determined COVID-19 IgG/IgM Antibody Test and COVID-19 Viral Antigen Test products were adulterated because products were sold without approval, clearance, or authorization from the FDA while claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The agency instructed the company to cease the sale of its unauthorized tests. For more information, see the highlighted link below.
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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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