FDA recall Z-0680-2022

Product

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.

Distribution

Distributed to TX.

Key facts

Status

Terminated

Initiation date

2021-12-02

Report date

2022-03-09

Termination date

2024-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2022