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 (labeled for Research Use Only)
- Product Code: 83QKP
- Lot Numbers: See Recall Database Entry
- Devices Recalled in the U.S.: Up to 119,600
- Date Initiated by Firm: December 2, 2021
According to the labeling for the affected products, the Point of Care (POC) Celltrion DiaTrust COVID-19 Ag Rapid Test is labeled for Research Use Only (RUO) and not for use in diagnostic procedures.
The affected POC Celltrion DiaTrust COVID-19 Ag Rapid Test (labeled for Research Use Only) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the to detect the presence of SARS-CoV-2 spike proteins in human nasopharyngeal swab specimens. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.
Reason for Recall
Celltrion USA is recalling these specific lots of the POC DiaTrust COVID-19 Ag Rapid Test that are labeled for Research Use Only (RUO), because they were distributed to customers who would be unlikely to have used these tests for research use only and may not have the proper training to safely collect nasopharyngeal swab samples from people. Additionally, the labeling for the affected products includes uses that are outside of any authorized use (EUA210190) (for instance, use for someone suspected of COVID-19, testing is not limited to within 7 days of symptom onset, and for someone without symptoms, testing is not limited to repeat, or serial testing, performed twice between 24 and 48 hours after the first test). Emergency use of this test is limited to authorized laboratories.
Although there have been no reports of injuries, adverse health consequences or death associated with the use of these affected 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 or others who used the POC Celltrion DiaTrust COVID-19 Ag Rapid Test labeled for Research Use Only to test patients for COVID-19.
- People who were tested for COVID-19 using the POC Celltrion DiaTrust COVID-19 Ag Rapid Test labeled for Research Use Only.
What to Do
On December 2, 2021, Celltrion USA notified affected distributors and instructed them not to use this product and to complete and return the Acknowledgement and Receipt form.
If customers received the POC Celltrion DiaTrust COVID-19 Ag Rapid Test labeled Research Use Only (RUO), they should not be used for clinical diagnosis of COVID-19 or patient management. Test users and healthcare providers should discontinue clinical use of the POC Celltrion DiaTrust, COVID-19 Ag Rapid Test labeled Research Use Only (RUO), quarantine the tests, and contact Celltrion USA for information on how to return unused product or alternatively, discard or destroy these products.
Customers with questions or concerns about this recall may contact Celltrion USA at [email protected].
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.