Three is turning out to be a not-so-magical number for Celltrion, which this week racked up a third Class I tag in less than two months for yet another recall of its rapid antigen COVID-19 tests.
This time around, the FDA handed down its strictest categorization for a recall that the South Korean company initiated at the beginning of this month after discovering that some of its DiaTrust coronavirus diagnostic kits may have been distributed to unauthorized users.
The FDA has authorized the rapid antigen test only for use at the point of care. It requires a nasopharyngeal sample collected by a healthcare provider, which is then meant to be processed only by a CLIA-certified laboratory.
Per Celltrion’s April 4 recall, however, some of the tests distributed in recent months may have been sent to healthcare providers without CLIA certification. If that occurred and the tests were performed by unqualified and untrained personnel, they could be at a higher risk of returning incorrect results. There’s also a higher risk of patient injury, since specific training is required to ensure nasopharyngeal swabs are collected safely.
The recall affects more than 12,600 packages distributed around the U.S. in the three-month period between last December and February of this year. That shakes out to as many as 311,100 individual testing units.
No reports of injury or death have yet been reported to Celltrion or the FDA in connection with the recall, but the agency warned that improper COVID testing could lead to the unmitigated spread of the virus.
Celltrion contacted all distributors of the tests and asked them to share details of the recall with every one of their customers. They’re also required to collect documentation of each buyer’s CLIA certification, and if any customers aren’t certified, they’ll have to immediately stop using the tests and return them to the distributor.
The latest Class I recall comes a little over a month after Celltrion’s last mishap. That case was similar. It stemmed from the company finding that some of its DiaTrust point-of-care tests allotted for research use only could have been distributed to users unaware of the restriction and potentially likely to use the tests to make clinical diagnoses. The warning spanned up to 119,600 antigen tests.
That recall, in turn, came barely a week after another Class I event for the company, where about 45,500 tests distributed between June and December 2021 came under scrutiny. Those lots not only were mislabeled with a shelf life several months longer than the FDA allowed but were also found to return a higher-than-average number of false-positive results.
Neither of the March recalls were linked to any reports of injuries, deaths or other serious health consequences.