The FDA has identified this as a Class I withdrawal, the most severe form of withdrawal. Use of these devices could result in serious injury or death.
- Product name: Celltrion DiaTrust COVID-19 Ag Rapid Test
- Product code: 83QKP
- Part numbers: See Recall Database Entry
- Distribution Dates: June 2, 2021 to December 21, 2021
- Units recalled in the United States: 45,500
- Date initiated by the company: 28 February 2022
Using the device
The Celltrion DiaTrust COVID-19 Ag Rapid Test is designed 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) inoculation sample from patients. The sample is collected by healthcare providers.
Reason for revocation
Celltrion USA is recalling specific batches of the DiaTrust COVID-19 Ag Rapid Test due to a large number of false positive reports. A false-positive antigen test result can lead to a delay in both the correct diagnosis and treatment of the actual cause of a person’s disease. False-positive results can also lead to more spread of the SARS-CoV-2 virus if presumed positive people are housed together.
In addition, the labeling of the tests for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use permit specifies that these tests may only be used for 12 months.
The use of the affected product can cause serious health consequences and death.
Although there have been no reports of injuries, health consequences or deaths associated with the use of the affected products, false positive or false negative results from misuse of these tests may lead to further exposure of uninfected persons to SARS-CoV-2- virus. There are also serious risks of injury if a person who is not trained to collect a nasopharyngeal swab specimen attempts to do so.
Who may be affected
- Healthcare professionals using Celltrion DiaTrust COVID-19 Ag Rapid Test to test patients for COVID-19.
- Individuals 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
- Fill out and return the confirmation and receipt form
Customers with questions or concerns about this recall can contact Celltrion USA at [email protected].
How do I report a problem?
Healthcare professionals and consumers may report side effects or quality issues they experienced using these devices for MedWatch: FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail or fax.