Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA device recall Z-0953-2022 · posted 2022-04-27 · Terminated
Recall details
- Recalling firm
- CELLTRION USA INC
- Reason for recall
- Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- QKP
- Quantity affected
- 12,632 kits
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-04-01
- Date posted
- 2022-04-27
- Date terminated
- 2024-06-11
- Location
- Jersey City, NJ
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