Device product
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Z-0677-2025
Product summary
- Firm
- Diasorin Inc.
- Event
- Event 95829
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21905 units
- Official record key
device-enforcement:Z-0677-2025
Official wording
Reason: 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.
Code information: 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 pattern: Worldwide
Derived failure modes
-
Unknown
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.