# FDA recall Z-0677-2025

> **Diasorin Inc.** · Class II · device recall initiated 2024-11-07.

## Product

DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

## Reason for recall

Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0677-2025
- **Recalling firm:** Diasorin Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-07
- **Report date:** 2024-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stillwater, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0677-2025

## Citation

> AI Analytics. FDA recall Z-0677-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0677-2025. Source: US FDA. Licensed CC0.

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