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

FDA device recall Z-0731-2022 · posted 2022-03-08 · Open, Classified

Recall details

Recalling firm

CELLTRION USA INC

Reason for recall

Kits were labeled with incorrect expiration dates.

Action taken

An URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers. Immediate Actions to be taken by You: 1. Examine your inventory for affected product. Please identify the LOT number printed on the outer box to determine whether the products you received are from lots COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007. 2. If you identify kits from the lots above in your inventory, quarantine the products and do not use them. 3. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007, please contact celltrionusa.CS@celltrion.com and Celltrion USA, Inc. will provide the shipping label for return to the address below. Celltrion USA, Inc. One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA 4. Please complete the enclosed Acknowledgement and Receipt Form with the information requested and return the form in accordance with the instructions on the form. Please complete this form even if you do not have the product on hand. For additional questions, please contact Celltrion USA by calling +1 (201) 320-2023 Monday through Friday, 9:00 AM to 6:00 PM or email to celltrionusa.CS@celltrion.com.

Root cause

Incorrect or no expiration date

Status

Open, Classified

Product code

QKP

Quantity affected

1,228,200 tests

Distribution

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

Date initiated

2022-02-25

Date posted

2022-03-08

Location

Jersey City, NJ