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

Recall date

December 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0680-2022

FDA classification

Class I

Brand / firm

CELLTRION USA INC

Sold / distributed

Distributed to TX.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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