FDA Medical devices recall ·
DiaSorin LIAISON Q.S.E.T. Device Plus recall
- Recall number
- Z-0677-2025
- Date
- (initiated November 7, 2024)
- Company / brand
- Diasorin Inc.
1951 Northwestern Ave S, Stillwater, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21905 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 80567713190605F, Lot Numbers: 225084, 232094, 234114, 259144, 221214, 252244, 230094, 224124, 205144, 228174, 228224, 223274, 219104, 217134, 233154, 236174, 224244, 232294, 229224, 251234, 221294, 210204, 223244, 222314
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0677-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.