CELLTRION USA INC: Medical Device Recall in 2022 - (Recall #: Z-0731-2022)

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 II

Date Initiated: February 25, 2022

Date Posted: March 16, 2022

Recall Number: Z-0731-2022

Event ID: 89640

Reason for Recall:

Kits were labeled with incorrect expiration dates.

Status: Ongoing

Product Quantity: 1,228,200 tests

Code Information:

Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007

Distribution Pattern:

The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated