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

FDA Recall #Z-0680-2022 — Class I — December 2, 2021

Recall #Z-0680-2022 Date: December 2, 2021 Classification: Class I Status: Terminated

Product Description

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

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.

Recalling Firm

CELLTRION USA INC — Jersey City, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

8080 kits originally distributed; 726 kits redistributed

Distribution

Distributed to TX.

Code Information

Lots COVGCCF0001, COVGCCF0002

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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