FDA marks Celltrion’s recent recall of 310,000 COVID-19 tests as a Class I event
FDA marks Celltrion’s recent recall of 310,000 COVID-19 tests as a Class I event

FDA marks Celltrion’s recent recall of 310,000 COVID-19 tests as a Class I event

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Diving card:

  • Celltrion is revocable as many as 311,100 of their COVID-19 rapid antigen tests that may have been sent to unauthorized users who lack CLIA certification.
  • The recall, which the FDA labeled a Class I event, stems from the emergency approval of the Point of Care DiaTrust COVID-19 Ag Rapid Test, which only covers the use of laboratories with CLIA certification. Tests delivered to uncertified users increase the risk of false results, the agency warned.
  • 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 experienced problems including labeling errors and distribution of kits intended for research use.

Diving insight:

Celltrion is one more Covid-19 test manufacturers faced compliance issues in recent months. The FDA named the U.S. entity in the Korean company as one of a number of companies that withdrew tests from the market in February after discovering that 162,000 fast antigen sets intended for use in Europe were available in America. Celltrion later withdrew more than 8,000 tests across two recalls related to the shipment of kits that were quarantined for false positives or intended for research use only.

The latest recall again concerns 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 who lack the necessary certification to use them under the terms of the emergency use permit. The FDA explained why this is a problem in its Class I reminder.

“Emergency use of these tests is restricted to authorized laboratories, and use of these tests in unauthorized environments (for example, customers without CLIA certification) may pose an increased risk of false results, as the persons performing these tests may not have the qualifications. or the training to administer them properly and safely, “the FDA wrote.

The Agency has not yet become aware of reports of injuries, adverse health consequences or deaths associated with the use of the recalled products. Still, the FDA believes there is a risk that improper use of the tests could cause problems, including false positives or negatives. Likewise, if untrained people collect samples, a task that should be performed by health care providers, the regulator warns that serious injuries can occur. In light of the issues, the FDA categorized the recall as a Class I event.

Celltrion, which has a contract of $ 626 million with the Department of Defense, wrote to its clients 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 requested that the kits be quarantined and returned to the distributor.

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