medical Class II Updated 2024-12-18

Diasorin Inc. recalls DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended

Recalled Product

DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: 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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →