Reported Dec 18, 2024 · Ongoing
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diasorin Inc. · 1951 Northwestern Ave S · Stillwater, MN · 55082-7536
Is this the product you have?
- DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
- Lot codes and dates
- UDI/DI 80567713190605F
- Lot Numbers
225084232094234114259144221214252244230094224124205144228174228224223274219104217134233154236174224244232294229224251234221294210204223244222314
- Amount recalled
- 21905 units
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.
This product could cause temporary or reversible health problems — stop using it.
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