DiaSorin LIAISON Q — Class II medical device recall Z-0677-2025
Ongoing recall by Diasorin Inc., reported 2024-12-18. Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal
| Recall number | Z-0677-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasorin Inc., Stillwater, MN, United States |
| Recall initiated | 2024-11-07 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Quantity | 21,905 units |
| Reason classes | packaging |
| Lot numbers | 205144, 210204, 217134, 219104, 221214, 221294, 222314, 223244, 223274, 224124, 224244, 225084, 228174, 228224, 229224, 230094, 232094, 232294, 233154, 234114, 236174, 251234, 252244, 259144 |
| Model numbers | 319060 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0677-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.