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Terminated

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

FDA Recall Z-0659-2022 · Posted 2022-03-02

Recalling FirmCELLTRION USA INC
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-12-28
Date Terminated2024-06-10
Product Quantity243 kits (6,075 tests)

Reason for Recall

The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.

Firm Action

The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.

Root Cause

Process control

Distribution Pattern

US distribution to CA, FL, NJ, NY, PA, SC.

Official Source

View FDA Recall →

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

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