UPDATE: March 9, 2022: Celltrion is recalling 1.2 million COVID-19 tests after they were labeled with the incorrect expiration dates. The recall, labeled by the FDA as a Class II event, is one of several recalls of the company’s rapid antigen tests in recent weeks. 

Earlier this month, the company had initiated two recalls of its rapid COVID-19 tests that were improperly distributed, both of which were labeled Class I events by the FDA. 

For the first, Celltrion is recalling 243 rapid antigen test kits that were erroneously released to customers in December, according to the FDA’s enforcement report. Those tests were part of a lot that had been placed under quarantine in September, after complaints of false positives.

The second, larger recall affects 8,080 test kits that were primarily distributed in Texas. The FDA said the tests were designed for research use only, but they were sent out to customers that were unlikely to use them for research purposes, with a letter assuring distributors that the tests could be used for clinical diagnosis. A portion of the tests, about 726 kits, were redistributed to customers after they had been returned.

In February, the company also recalled 162,000 tests that were intended to be distributed in Europe, but had not been authorized for use in the U.S.

Dive Brief:

• 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 the companies have all received emergency use authorizations for antigen tests, FDA has learned that some versions of their diagnostics that are not authorized, cleared or approved for distribution or use in the U.S. have entered the country.
• Acon, Celltrion and SD Biosensor are now recalling the unauthorized tests. The Celltrion recall covers at least 162,000 tests that were diverted from Europe to the U.S., which struggled to meet demand as omicron hit. Last month, Roche partner SD Biosensor announced a recall of illegally imported rapid antigen COVID-19 tests from the U.S. and said it was in the process of investigating how the products entered the country.

Dive Insight:

All the affected tests appear to be products originally destined for the European market. The packaging of the Acon test 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 E25Bio and 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.

Elise Reuter contributed to this update.