Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Company
- Celltrion Usa Inc
- Recall Initiated
- April 1, 2022
- Posted
- April 27, 2022
- Terminated
- June 11, 2024
- Recall Number
- Z-0953-2022
- Quantity
- 12,632 kits
- Firm Location
- Jersey City, NJ
Reason for Recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Distribution
US Nationwide distribution.
Lot / Code Info
All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Root Cause
Other
Action Taken
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.