CELLTRION USA INC: Medical Device Recall in 2022 - (Recall #: Z-0659-2022)

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 28, 2021

Date Posted: March 9, 2022

Recall Number: Z-0659-2022

Event ID: 89508

Reason for Recall:

The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.

Status: Terminated

Product Quantity: 243 kits (6,075 tests)

Code Information:

Lot COVGCCM0008

Distribution Pattern:

US distribution to CA, FL, NJ, NY, PA, SC.

Voluntary or Mandated:

Voluntary: Firm initiated