Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
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.
- 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
The Point of Care (POC) 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 specific lots of the POC DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. 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 for the affected POC products 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 affected POC products, 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 POC Celltrion DiaTrust COVID-19 Ag Rapid Test to test patients for COVID-19.
- People who were tested for COVID-19 using the POC 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 the Acknowledgement and Receipt Form
Customers with questions or concerns about this recall may contact Celltrion USA at CelltrionUSA@celltrion.com.
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.