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Terminated

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

FDA Recall Z-0680-2022 · Posted 2022-03-02

Recalling FirmCELLTRION USA INC
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-12-02
Date Terminated2024-06-10
Product Quantity8080 kits originally distributed; 726 kits redistributed

Reason for Recall

Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.

Firm Action

On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.

Root Cause

Employee error

Distribution Pattern

Distributed to TX.

Official Source

View FDA Recall →

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

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