FDA warns about unauthorized versions of rapid COVID-19 tests – MedTech Dive

Dive Brief:

All the affected tests appear to be products originally destined for the European market. The packaging of the Acontest carries a CE mark, while the packaging of the SD Biosensor test includes a statement about how long it takes to deliver results that is translated into English, Spanish, French and Portuguese. Celltrion's recall notice confirms its problem relates to the importation of the European version of its test.

After discovering what was happening, Celltrion"sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S."and "demanded return of all EU product from distributors'inventory and demanded removal of all EU DiaTrust Tests from the U.S."The company has also written to "all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU."

The importation of European tests into the U.S. potentially reflects an imbalance in the availability of rapid antigen kits. While the U.K. faced a short period in which government-provided rapid antigen tests were in and out of stock, access to the kits has generally been less constrained in Europe than in the U.S., creating incentives for distributors to divert them to the place where demand exceeded supply.

Those diversions have brought tests that lack FDA authorization into the U.S. FDA warned that the tests carry a risk of false negatives and false positives and advised healthcare providers who have used the kits in the past two weeks to consider retesting their patients with an authorized or cleared alternative if they suspect an inaccurate result.

The agency has not received reports of injuries, adverse health consequences or death associated with any of the tests, and categorized the Celltrion recall as a Class II event. FDA is yet to publish details of the recalls by Acon and SD Biosensor.

Since late January, FDA has issued a flurry of notices about rapid COVID-19 tests with public warnings about unauthorized tests including E25Bioand Empowered Diagnostics. The agency classified Empowered Diagnostics' recall as a Class I event, although at the time FDA said there were no reports of adverse health consequences or death from use of the tests.

Read the original here:

FDA warns about unauthorized versions of rapid COVID-19 tests - MedTech Dive