Z-0731-2022 Class II Ongoing

Recalled by CELLTRION USA INC — Jersey City, NJ

Recall Details

Product Type
Devices
Report Date
March 16, 2022
Initiation Date
February 25, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,228,200 tests

Product Description

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

Reason for Recall

Kits were labeled with incorrect expiration dates.

Distribution Pattern

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

Code Information

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