Dive Brief:
- Celltrion is recalling as many as 311,100 of its COVID-19 rapid antigen tests that may have been sent to unauthorized users that lack CLIA certification.
- The recall, which the FDA labeled a Class I event, stems from the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test, which only covers use by laboratories with CLIA certification. Tests provided to uncertified users raise the risk of false results, the agency warned.
- The FDA has issued a series of Class I and II recalls covering more than 1 million Celltrion COVID-19 tests in recent months as it has learned of problems including labeling errors and the distribution of kits intended for research use.
Dive Insight:
Celltrion is one several COVID-19 test manufacturers facing compliance issues in recent months. The FDA named the U.S. unit of the Korean company as one of a number of businesses that pulled tests from the market in February after discovering 162,000 rapid antigen kits intended for use in Europe were available in America. Celltrion later withdrew more than 8,000 tests across two recalls related to the shipping of kits that were quarantined for false positives or only intended for research use.
The latest recall again relates to the distribution of kits. This time, as many as 311,100 Point of Care DiaTrust COVID-19 Ag Rapid Tests have been sent to users that lack the certification needed to use them under the terms of the emergency use authorization. The FDA set out why that is a problem in its Class I recall notice.
“Emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA-certification) may present an increased risk of false results as the persons performing these tests may not have the qualifications or training to properly and safely administer them,” the FDA wrote.
The agency is yet to learn of reports of injuries, adverse health consequences or death associated with the use of the recalled products. Still, the FDA believes there is a risk that improper use of the tests may cause problems including false positives or negatives. Equally, if untrained people collect samples, a task that should be done by healthcare providers, the regulator warns serious injuries may occur. In light of the issues, the FDA categorized the recall as a Class I event.
Celltrion, which has a $626 million contract with the Department of Defense, wrote to its customers about the recall last month. The company asked customers to provide a CLIA Certificate Number and contact information to its distributor. If a company lacked CLIA certification, Celltrion asked for the kits to be quarantined and returned to the distributor.
