Medical Device Recall: DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc. · November 7, 2024
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
Quantity Affected
21905 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0677-2025
Status: ongoing
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