NEW YORK – The US Food and Drug Administration released a warning letter Tuesday requiring Industry Lab Diagnostic Partners to immediately stop selling its SARS-CoV-2 at-home sample collection kit, which has not been approved or authorized by the agency.
The Nashville, Tennessee-based company's COVID-19 Testing Kit requires users to self-collect a nasopharyngeal swab sample and send it to the firm for testing. In its letter dated Nov. 20, FDA's Center for Devices and Radiological Health said the product did not have an approved application for premarket approval or investigational device exemption.
It also said the product was misbranded, because the agency wasn't told of Industry Lab Diagnostic Partners' intent to introduce the kit into commercial distribution.
FDA also cited the potential risks of at-home collection, namely that an untrained user may not be able to safely and properly collect the sample and potential issues with shipping, as well as the stability of the sample as a result of the time between collection and testing.