FDA recall Z-0080-2023

LUMINOSTICS, INC dba CLIP HEALTH · Class II · device

Product

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

Reason for recall

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

Distribution

US nationwide distribution

Key facts

Status
Ongoing
Initiation date
2022-09-02
Report date
2022-10-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fremont, CA, United States

Primary source

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