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Terminated

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

FDA Recall Z-0953-2022 · Posted 2022-04-27

Recalling FirmCELLTRION USA INC
Recall StatusTerminated
Product CodeQKP
Date Initiated2022-04-01
Date Terminated2024-06-11
Product Quantity12,632 kits

Reason for Recall

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Firm Action

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

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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