FDA Devices recall · Reported December 18, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
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 P…
Diasorin Inc. recalled DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of… - a moderate-severity action.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of… was recalled by Diasorin Inc. in December 18, 2024. Reason: Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's interna…. Check the official notice for the remedy. Verify recall #Z-0677-2025 with the FDA Devices before acting.
The recall
Diasorin Inc. issued this moderate-severity FDA Devices recall-Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's interna….
- Moderate
- severity level
- 22K units
- affected scope
- Class II
- classification
- December 18, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0677-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0677-2025 |
| Date reported | December 18, 2024 |
| Date initiated | November 7, 2024 |
| Recalling firm | Diasorin Inc. |
| Firm location | Stillwater, MN |
| Affected scope | 21905 units |
| Distribution | Worldwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0677-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026