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Terminated

Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

FDA Recall Z-0558-2022 · Posted None

Recalling FirmCELLTRION USA INC
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-12-01
Date Terminated2024-06-17
Product Quantity162,000 ea

Reason for Recall

The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.

Firm Action

Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. In addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the state of CA.

Official Source

View FDA Recall →

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

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