DiaTrust COVID-19 Ag Rapid Tests Recalled By Celltrion Over False Positive, Shelf Life Concerns

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Celltrion USA COVID-19 Rapid Test Recall Overview: 

• Who: Celltrion USA has issued a recall for its Celltrion DiaTrust COVID-19 Ag Rapid Tests.
• Why: The tests were recalled over concerns they can give false positive test results and are labeled as having a longer shelf life than what is authorized by the U.S. Food and Drug Administration.
• Where: The recall is nationwide.

Celltrion USA has issued a recall for its Celltrion DiaTrust COVID-19 Ag Rapid Tests over concerns they have an unauthorized shelf life and can record false positive test results. 

The recall, which was published by the U.S. Food and Drug Administration (FDA) on Mar. 15, is being classified as a Class I recall, meaning use of the devices can lead to serious injury or death. 

Celltrion USA is recalling its COVID-19 Ag Rapid Tests are receiving numerous reports of false positive test results from individuals trying to find out if they have COVID-19, according to the recall. 

The recall was initiated on Feb. 28 and involves 45,500 devices distributed in the U.S. between June 2, 2021, and Dec. 21, 2021. 

The FDA says a false positive test result can delay the correct diagnosis and subsequent treatment for an illness and lead to the spread of COVID-19 if “presumed positive people are housed together.” 

Celltrion COVID-19 Tests Have Longer Than Authorized Shelf Life 

The shelf life for the tests is also labeled as being 18 months, despite emergency use authorization from the FDA stating the tests are only good to use for 12 months, according to the recall. 

There have been no reports of injury, adverse health consequences or death occurring due to the use of the Celltrion USA tests, the FDA says. 

Celltrion USA sent letters to affected customers and distributors on Feb. 28 that instructed them to stop using and return all of the unused products, according to the recall. 

Customers with concerns who want to contact Celltrion USA directly can reach the company by email.

The FDA recalled COVID-19 tests manufactured by LuSys Laboratories earlier this month after determining they were not authorized to be sold in the United States and had not been verified as able to provide accurate results. 

Last month, meanwhile, SD Biosensor issued a voluntary recall for its STANDARD Q COVID-19 Ag Home Test after confirming reports that they had been illegally imported into the country. 

Have you used a Celltrion DiaTrust COVID-19 Ag Rapid Test? Let us know in the comments! 

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