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Recall Observatory FDA recall evidence

Device product

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

Z-0680-2022

December 02, 2021

Class I

Product summary

Firm
CELLTRION USA INC
Event
Event 89516
Status
Terminated
Classification
Class I
Quantity
8080 kits originally distributed; 726 kits redistributed
Official record key
device-enforcement:Z-0680-2022

Official wording

Reason: 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.

Code information: Lots COVGCCF0001, COVGCCF0002

Distribution pattern: Distributed to TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.