Recall Z-0677-2025 ยท NXO Calprotectin, Fecal
Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
| Date | Dec 12, 2024 (initiated Nov 7, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | DiaSorn issued an Urgent Field Safety Notice - Medical Device Recall notice to its consignees on 11/07/2024 via email. The notice explained the issue with the product, risk to health, and requested the following: "Ac xons to be taken by the Customer/User " No need to review past patient results. " Devices should be inspected for loose clear caps prior to use. The user should confirm that the clear cap is tight by grasping the cap and twisting. If the cap is loose, the device should be discarded. Do not attempt to use the device as the loose clear cap may have allowed buffer to leak, causin |
| Quantity | 21905 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus DiaSorin, Inc., Jul 26, 2022 |