FDA-Device2022-10-19Class II

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

LUMINOSTICS, INC dba CLIP HEALTH
Hazard

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

Sold states
US nationwide distribution
Affected count
10037 boxes of 25
Manufactured in
46430 Fremont Blvd, N/A, Fremont, CA, United States
Products
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2023

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