The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test
- Product Code: 83QKP
- Lot Numbers: See Recall Database Entry
- Distribution Dates: June 2, 2021, to December 21, 2021
- Devices Recalled in the U.S.: 45,500
- Date Initiated by Firm: February 28, 2022
Device Use
The Celltrion DiaTrust COVID-19 Ag Rapid Test is intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasopharyngeal (deep inside the nose to the back of the throat) swab sample from patients. The sample is collected by healthcare providers.
Reason for Recall
Celltrion USA is recalling the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports for some tests. A false-positive antigen test result may lead to a delay in both the correct diagnosis and treatment for the actual cause of a person's illness. False-positive results could also lead to more spread of the SARS-CoV-2 virus if presumed positive people are housed together.
Additionally, the tests’ labeling includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months.
The use of the affected product could cause serious adverse health consequences and death.
Although there have been no reports of injuries, adverse health consequences or death associated with the use of the test, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.
Who May be Affected
- Health care personnel who used the Celltrion DiaTrust COVID-19 Ag Rapid Test to test patients for COVID-19.
- People who were tested for COVID-19 using the Celltrion DiaTrust COVID-19 Ag Rapid Test.
What to Do
On February 28, 2022 Celltrion USA sent letters to some affected distributors and customers with the following instructions:
- Discontinue use
- Return all unused product
- Complete and return Acknowledgement and Receipt Form
Contact Information
Customers with questions or concerns about this recall may contact Celltrion USA at CelltrionUSA@celltrion.com.
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
