CELLTRION USA INC: Medical Device Recall in 2022 - (Recall #: Z-0953-2022)

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: April 1, 2022

Date Posted: May 4, 2022

Recall Number: Z-0953-2022

Event ID: 89965

Reason for Recall:

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Status: Terminated

Product Quantity: 12,632 kits

Code Information:

All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated