Diasorin Inc.: Device Recall
Recall #Z-0677-2025 · 11/07/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0677-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Diasorin Inc.
- Status
- Ongoing
- Date Initiated
- 11/07/2024
- Location
- Stillwater, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21905 units
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.
Product Description
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Distribution Pattern
Worldwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.