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 Codes: 83QKP
- Lot Numbers: See recall database entry
- Distribution Dates: December 2021 to February 2022
- Devices Recalled in the U.S.: Up to 311,100 units
- Date Initiated by Firm: April 4, 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 the affected POC DiaTrust COVID-19 Ag Rapid Test because it may have been distributed to unauthorized users. This test is authorized for use only by laboratories with CLIA certification and a corresponding CLIA Certificate Number (CCN). CLIA-certified laboratories must meet specific criteria that qualify them to perform diagnostic tests. Emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA -certification) may present an increased risk of false results as the persons performing these tests may not have the qualifications or training to properly and safely administer them.
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
- Distributors of the Celltrion POC DiaTrust COVID-19 Ag Rapid Test
- Test users at non-CLIA certified facilities that used the Celltrion POC DiaTrust COVID-19 Ag Rapid Test
- People who were self-tested for COVID-19 using the Celltrion POC DiaTrust COVID-19 Ag Rapid Test
What to Do
On April 5, 2022, Celltrion USA notified customers about this issue by email and instructed them to provide a CLIA Certificate Number and contact information to their distributor.
Customers without CLIA certification were instructed to:
- Not use any test kits currently in inventory and quarantine them.
- Return the product to the distributor along with an acknowledgement and receipt form that was attached to the email. The distributor can provide shipping labels for product return.
Customers with questions or concerns about this recall may contact their distributors or Celltrion USA at celltrionusa.CS@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.