CELLTRION USA INC: Medical Device Recall in 2022 - (Recall #: Z-0558-2022)

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, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

Product Classification:

Class II

Date Initiated: December 1, 2021

Date Posted: February 9, 2022

Recall Number: Z-0558-2022

Event ID: 89455

Reason for Recall:

The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.

Status: Terminated

Product Quantity: 162,000 ea

Code Information:

All lots

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated