# FDA recall Z-0080-2023

> **LUMINOSTICS, INC dba CLIP HEALTH** · Class II · device recall initiated 2022-09-02.

## 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

- **Recall number:** Z-0080-2023
- **Recalling firm:** LUMINOSTICS, INC dba CLIP HEALTH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-02
- **Report date:** 2022-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0080-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0080-2023. Source: US FDA. Licensed CC0.

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