Z-0677-2025Class II

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

Name: Z-0677-2025 DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool...
Creator: Diasorin Inc.
Published: 2024-11-07
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2024-11-07 / Open, Classified / root cause: manufacturing process

FDA source

Diasorin Inc. began a recall of DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens on 2024-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0677-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-07
Posted: 2024-12-12
Recalling firm: Diasorin Inc.
Product: DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Product code: NXO Calprotectin, Fecal
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.
Root cause tag: manufacturing process
FDA 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, 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); [email protected]
Quantity in commerce: 21905 units
Distribution: Worldwide
Product codes and lots: UDI/DI 80567713190605F, Lot Numbers: 225084, 232094, 234114, 259144, 221214, 252244, 230094, 224124, 205144, 228174, 228224, 223274, 219104, 217134, 233154, 236174, 224244, 232294, 229224, 251234, 221294, 210204, 223244, 222314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0677-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-12

Product code NXO

K213858Class IILIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. / cleared 2022-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)