FDA-Device2024-12-18Class II
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc.
Hazard
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.
Sold states
Worldwide
Affected count
21905 units
Manufactured in
1951 Northwestern Ave S, Stillwater, MN, United States
Products
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0677-2025Don't want to check this manually?
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