FDA warns of counterfeit COVID-19 diagnostic tests

The FDA has said it is aware of fake at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed in the US that could generate false results.

The counterfeits of the FDA-authorised Flowflex and iHealth antigen home test kits could make it more likely that users unknowingly spreading COVID-19, and may delay or stop appropriate medical treatment for the infection.

The agency said it is not aware of any counterfeit tests distributed by the US government test distribution programmes, so it is most likely that people who choose to buy their own test kits will be affected by the scam.

Among the ways to spot one of the fakes is poor print quality of images or text on the outside box label or instructions for use included in the box, missing information on the outer box such as the lot number, expiration date, or barcode or QR codes, typos or grammatical mistakes, and missing components.

Flowflex test kits made by ACON Laboratories have been authorised for use by the FDA, and the fakes are an attempt to mimic the genuine product. Earlier, the FDA warned that tests from a company calling itself ACON Biotech should also not be used as they had not been authorised by the regulator.

The fake iHealth kits are hard to spot as there are not many easily identifiable differences between them and the legitimate tests, said the FDA, which said it is continuing to work with the company on how best to identify the knock-offs.

More information is available here.

Image by analogicus from Pixabay