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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.

More information about each unapproved COVID-19 test can be found below (use the links to read each warning letter):

  • Company: Block Scientific. Products: QUIKPACII COVID-19 ANTIBODY TEST KIT and Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold) (also referred to as [CoV19-AG] COVID-19 Antigen Rapid Test (Colloidal Gold) Long Island Biotech). These test kits were sold throughout the US, but they are not approved by the FDA, so they are adulterated and misbranded.
  • Company: Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs. Product: COVID-19 IgM/IgG Rapid Test (also referred to as COVID-19 On-Site Rapid Test; TM TEST KITS; TM Test Kits, CoVID-19 Rapid Antibody Serology Test; COVID-19 IgG/IgM Rapid Test Cassette, and 2019-nCov-SARS (COVID-19) IgM/IgG Antibody Test Kit). This test kit was sold throughout the US, but it is not approved by the FDA, so it is adulterated and misbranded. In addition, the product was stated to be "FDA APPROVED" in a fact sheet, which is illegal to claim without actual FDA approval.
  • Company: Ikcon Investments, Inc dba Ikcon Medical. Products: Akcutest COVID-19 Antibody Test (also referred to as Akcutest Kit (25 tests per Kit $20/test) COVID-19 Rapid Tests, Akcutest Sample Kit (3 tests per Kit $33/test) COVID-19 Rapid tests, and Akcutest Serological Rapid Test) and Lumigenik COVID-19 Antigen Rapid Test (also referred to as Lumigenik Sample Kit (3 tests per Kit $50/test) COVID-19 Rapid Tests, Lumigenik Kit (25 tests per Kit $30/test) COVID-19 Rapid Tests, and Lumigenik Antigen Rapid Test). These test kits were sold throughout the US, but they are not approved by the FDA, so they are adulterated and misbranded. In addition, the Akcutest Kit was promoted with pictures of the FDA logo, implying it was approved by the FDA, which is incorrect and illegal to claim.
  • Company: Fast Masks USA LLC. Products for sale: At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests), and COVID-19 Antibodies Test Kit. Products distributed: 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. These test kits were sold throughout the US, but they are not approved by the FDA, so they are adulterated and misbranded. In addition, the At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests) and COVID-19 Antibodies Test Kit were stated to be "FDA Approved" on the company's website, which is illegal to claim without actual FDA approval.
  • Company: Sethi Laboratories. Products: Rapid COVID-19 Antibody Self Test Kit (also referred to as Novel Coronavirus Antibody Test Kit, COVID-19 ANTIBODY SELF TEST KIT, and AB Rapid Kit) and Rapid COVID-19 Antigen Self Test Kit (also referred to as Novel Coronavirus Antigen Test Kit and Sethi Laboratories COVID-19 Antigen test). These test kits were sold throughout the US, but they are not approved by the FDA, so they are adulterated and misbranded. In addition, the test kits were stated to be "FDA Emergency Use Authorized" on the company's website, which is illegal to claim without actual FDA approval.

An FDA director has previously spoken out against companies committing fraud to take advantage of the pandemic, stating, "When tests are marketed inappropriately, with inaccurate or misleading claims -- such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not -- they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted."

The FDA instructed each company to send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps it has taken to correct these violations.

See ConsumerLab's answer to the questions How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free? and What are natural remedies for coronavirus (COVID-19)? Do supplements like zinc, vitamin C, or herbals work?

See Related Warnings:

FDA Warns Sellers of Unapproved COVID-19 Tests, CBD Products

FDA Warns Consumers about Fraudulent Tests, Vaccines, and Treatments for COVID-19

FDA Warns Seller of Unapproved "COVID-19 test package"

FDA Warns Seller of Unapproved "Wondfo Novel Coronavirus Antibody Detection Kit"