- FDA has warned people against using certain COVID-19 antigen tests from Acon Laboratories, Celltrion and SD Biosensor due to the risk of false results when using the unauthorized diagnostics.
- While companies have everything received emergency use permits for antigen testing, the FDA has learned that some versions of their diagnostics that are not approved, approved, or approved for distribution or use in the United States have entered the country.
- Acon, Celltrion and SD Biosensor are now recalling the unauthorized tests. That Celltrion recall covers at least 162,000 tests that were redirected from Europe to the US, which struggled to meet demand when omicron hit. Last month, Roche partner SD Biosensor announced a recall of illegally imported fast antigen COVID-19 tests from the United States and said it was in the process of investigating how the products entered the country.
All the tests concerned appear to be products originally intended for the European market. The packaging for the Acon test is CE marked, while the packaging for the SD Biosensor test contains a statement of how long it takes to deliver results that have been translated into English, Spanish, French and Portuguese. Celltrion’s recall notice confirms that its problem concerns the import of the European version of the test.
After discovering what happened, Celltrion sent “termination and waiver letters to distributors who illegally distributed non-EUA products in the US” and “demanded the return of all EU products from distributors’ warehouses and demanded the removal of all EU DiaTrust tests from the US “The company has also written to” all EU distributors who warn against redirection and obtain confirmation that distributors only understand restrictions on distribution within the EU. “
Imports of European tests into the United States potentially reflect an imbalance in the availability of rapid antigen sets. While Britain faced a short period where government-supplied rapid antigen tests were in and sold out, access to kits has generally been less restricted in Europe than in USAwhich creates incentives for distributors to redirect them to the place where demand exceeded supply.
These redirects have brought tests that lack FDA authorization to the U.S. FDA, warned that the tests pose a risk of false negatives and false positives, and advised health care providers who have used the kits for the past two weeks to consider retesting their patients with an authorized or approved alternative if they suspect an inaccurate result.
The agency has not received reports of injuries, adverse health consequences or deaths associated with any of the tests, and categorized the Celltrion recall as a Class II event. The FDA has not yet released details of the recalls from Acon and SD Biosensor.
Since the end of January, the FDA has issued a barrage of rapid COVID-19 test notifications with public warnings about unauthorized tests, including E25Bio and Strengthened diagnostics. The agency classified Empowered Diagnostics’ recall as a Class I event, though the FDA at the time said there were no reports of adverse health consequences or deaths due to the use of the tests.