FDA-Device2022-03-16Class II

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

CELLTRION USA INC
Hazard

Kits were labeled with incorrect expiration dates.

Sold states
The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
Affected count
1,228,200 tests
Manufactured in
1 Evertrust Plz Ste 1207, N/A, Jersey City, NJ, United States
Products
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Official notice

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

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