Diasorin Inc.: Medical Device Recall in 2024 - (Recall #: Z-0677-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 7, 2024

Date Posted: December 18, 2024

Recall Number: Z-0677-2025

Event ID: 95829

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.

Status: Ongoing

Product Quantity: 21905 units

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

Voluntary or Mandated:

Voluntary: Firm initiated