CELLTRION USA INC: Medical Device Recall in 2022 - (Recall #: Z-0680-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: December 2, 2021

Date Posted: March 9, 2022

Recall Number: Z-0680-2022

Event ID: 89516

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.

Status: Terminated

Product Quantity: 8080 kits originally distributed; 726 kits redistributed

Code Information:

Lots COVGCCF0001, COVGCCF0002

Distribution Pattern:

Distributed to TX.

Voluntary or Mandated:

Voluntary: Firm initiated