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

FDA device recall Z-0677-2025 · posted 2024-12-12 · Open, Classified

Recall details

Recalling firm

Diasorin Inc.

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.

Action taken

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, causing insufficient buffer volume. " Customers should forward this communication to required individuals within the organization or to any organization where the potentially affected devices have been distributed. " Diasorin will replace any tubes found with loose clear caps. Contact Diasorin Product Support for replacement product." For questions or concerns, contact: Diasorin Product Support: 1-800-328-1482 Select Option 1 (U.S. and Canada); 1-651-351-5888 (Fax); productsupport@diasorin.com

Root cause

Process control

Status

Open, Classified

Product code

NXO

Quantity affected

21905 units

Distribution

Worldwide

Date initiated

2024-11-07

Date posted

2024-12-12

Location

Stillwater, MN

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