Fremont, CA, United States
LUMINOSTICS, INC dba CLIP HEALTH recalls
1 recall recorded since 2018, most recently on 2 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 September 2022
- Reason
- COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
- Distribution
- US nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0080-2023
- Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.