Recall Z-0953-2022— CELLTRION USA INC

Name: FDA recall Z-0953-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Class I · Terminated

Class I FDA medical device recall by CELLTRION USA INC, initiated 2022-04-01, terminated 2024-06-11. 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: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID..

Recalling firm: CELLTRION USA INC
Classification: Class I
Status: Terminated
Initiated: 2022-04-01
Terminated: 2024-06-11
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

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

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