Recall Z-0731-2022— CELLTRION USA INC

Name: FDA recall Z-0731-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-25

Class II · Ongoing

Class II FDA medical device recall by CELLTRION USA INC, initiated 2022-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Reason: Kits were labeled with incorrect expiration dates..

Recalling firm: CELLTRION USA INC
Classification: Class II
Status: Ongoing
Initiated: 2022-02-25
Firm location: Jersey City, NJ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.