FDA recall Z-0731-2022

CELLTRION USA INC · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2022-02-25
Report date
2022-03-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0731-2022