Recall Z-0953-2022
Celltrion USA Inc · initiated April 1, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Codes / lots: All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Reason for recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
FDA-determined 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.
Details
- Recall number
- Z-0953-2022
- Initiated
- April 1, 2022
- Posted by FDA
- April 27, 2022
- Terminated
- June 11, 2024
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 12,632 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Celltrion USA Inc, Jersey City, NJ