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

Recall date

November 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0677-2025

FDA classification

Class II

Brand / firm

Diasorin Inc.

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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