FDA recall Z-0677-2025

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.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2024-11-07

Report date

2024-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stillwater, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0677-2025