Celltrion’s range of COVID-19 diagnostic kits have once again fallen under the FDA’s microscope, just weeks after the regulator cracked down on sales of a version of the company's rapid antigen test that had been cleared only in the E.U., and another that was cleared in the U.S. but has been associated with a higher-than-average rate of false positives.
The latest safety warning concerns another version of the South Korean company’s antigen-detecting diagnostic, this one labeled for research use only.
According to a recall notice that Celltrion’s U.S. outpost filed in December, two lots of the research-specific, point-of-care tests were erroneously shipped to a distributor in Texas along with a note “assuring distributors that RUO tests could be used for clinical diagnosis.” As a result, the tests were then sold to customers that Celltrion said were “unlikely to use them for RUO purposes.”
When the company realized the mistake—which it attributed to “employee error”—it immediately contacted the distributor, who reported that the tests had already been used.
This week, the FDA gave the recall its Class I rating, denoting a heightened risk of serious injury or death associated with the affected products—though no such events have yet been reported.
The agency said that, in addition to potentially enabling the spread of the coronavirus, the tests also pose a danger if they’re administered by someone who hasn’t been properly trained in taking the nasopharyngeal swab samples that are required for the test.
The recall comprises as many as 119,600 rapid tests. Healthcare providers who purchased and administered the kits are advised to immediately stop using any leftovers and contact Celltrion USA about returning, discarding or destroying the products. They should also disregard any results they received from the tests and stop using them as definitive diagnoses of COVID or to guide patient management.
The Class I categorization comes just over a week after the FDA handed down yet another of the labels to Celltrion. In that case, the company initiated a recall on Feb. 28 of more than 45,000 of its DiaTrust rapid antigen tests, which were authorized for point-of-care use but have also been linked to a high number of false-positive results.
The FDA also noted that while its emergency use authorization for the kits stated that they had a shelf life of 12 months, their labels say they can be used for up to 18 months.
No adverse health consequences or deaths have been reported in connection with the affected tests.
Both of those recalls follow a separate regulatory action this month for yet another of Celltrion’s COVID tests when the FDA issued a safety warning regarding the unauthorized U.S. distribution of some of its DiaTrust rapid antigen tests.
Though the kits in question share the same name as one cleared by the FDA for stateside use, the recall specifically concerns a version of the diagnostic that was authorized only in the E.U. and can be differentiated from its American sibling by its green and white packaging. Celltrion began a recall of the 162,000 tests sold in the U.S. back in December when it said it had sent cease-and-desist letters to all distributors who had illegally sold the kits without the FDA’s OK.