COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues Four New Warning Letters for Adulterated and Misbranded COVID-19 Tests

FDA maze of regulations

FDA continues crackdown on unauthorized COVID-19 tests.

On Aug. 12, 2020, the US Food and Drug Administration (FDA) posted four warning letters that were issued during the last two weeks of July. These four warning letters addressed adulterated and misbranded COVID-19 tests that had not received emergency use authorization (EUA) and were not permitted to be marketed or sold in the United States. 

FDA warning letters were issued to:

  • Fair Price Labs, Inc. This warning letter addressed claims made about Fair Price Labs’ DROPTM SARS-CoV-2 virus ELISA IgG and IgM Self-Collection Test Kit. These claims included instructions that the test could be taken at home via a finger stick and that the specimen could be sent to their lab.
  • CoreMedica Laboratories, Inc. This warning letter addressed CoreMedica Laboratories’ COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection and Transport Kit, which claims to provide at-home antibody testing that involved a finger stick and mailing the sample to the company’s lab.
  • Holistic Health International, LLC. This warning letter addressed Holistic Health International’s SARS-COV-2 STOOL TEST (SCV), which claims to be a stool-based SARS-CoV-2 diagnostic test that could be collected at home.
  • AkivaMed Inc. This warning letter addressed AkivaMed’s COVID-19 Antibody Rapid Test Kit, which claims to be an at-home COVID-19 antibody test and does not describe how this test is collected.

The common factor in each of these adulterated and misbranded COVID-19 tests is that they are marketed for at-home use. These new warning letters indicate increased attention by the FDA to at-home tests. While the FDA recently released an EUA template for at-home COVID-19 testing, no EUAs have yet been issued for this kind of test.

Related Resources:

FDA Warning Letter: Fair Price Labs, Inc.

FDA Warning Letter: CoreMedica Laboratories, Inc.

FDA Warning Letter: Holistic Health International, LLC.

FDA Warning Letter: AkivaMed Inc.

FDA Warning Letters History