Recall Z-0080-2023— LUMINOSTICS, INC dba CLIP HEALTH
Class II · Ongoing
Class II FDA medical device recall by LUMINOSTICS, INC dba CLIP HEALTH, initiated 2022-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002. Reason: COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence..
- Recalling firm
- LUMINOSTICS, INC dba CLIP HEALTH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-02
- Firm location
- Fremont, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.