Celltrion COVID-19 Test (Celltrion) – Distribution Violation (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Brand
CELLTRION USA INC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
CELLTRION USA INC is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 due to Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Recommended Action
Per FDA guidance
On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022. The firm instructed distributors to communicate the recall to their affected customers, down to the user level. Customers who do not have CLIA IDs must return the product to their distributors.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026