Lower risk Medical device recall · FDA · Published November 7, 2024

Diasorin LIAISON Q.S.E.T. Device Plus: Leaking Caps Risk Incorrect Stool Test Results

Diasorin recalls LIAISON Q.S.E.T. Device Plus (REF 319060) due to loose caps causing buffer leaks. This may lead to incorrect stool test results. Affected units include specific lot numbers for stool specimen preparation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0677-2025Medical device Diasorin ›

Lower-risk 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.

Take action

Contact the company

Recalling firmDiasorin Inc.1951 Northwestern Ave S · Stillwater, MN 55082-7536

✎ GovInfoNow plain-language explainer

Diasorin is recalling LIAISON Q.S.E.T. Device Plus devices that may have loose clear caps, causing buffer leaks. This can result in incorrect stool test results if used improperly. The recall affects specific lot numbers sold for human stool specimen preparation. Read more at govinfonow.com/recall/53539-diasorin-liaison-q-s-e-t-device-plus-leaking-caps.

Source Summary by GovInfoNow · govinfonow.com/recall/53539-diasorin-liaison-q-s-e-t-device-plus-leaking-caps · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0677-2025

Cite this page

“Diasorin LIAISON Q.S.E.T. Device Plus: Leaking Caps Risk Incorrect Stool Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53539-diasorin-liaison-q-s-e-t-device-plus-leaking-caps. Based on FDA recall #Z-0677-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0677-2025%22&limit=1).

The FDA announced on November 7, 2024, that Diasorin Inc. is recalling the DiaSorin LIAISON Q.S.E.T. Device Plus due to loose clear caps that may allow buffer to leak. This defect can result in insufficient buffer volume and incorrectly high patient results for stool specimens.

How to tell if you have it

Brand: Diasorin
Product: DiaSorin LIAISON Q.S.E.T. Device Plus
REF: 319060
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
Units affected: 21,905

The hazard

Diasorin's internal investigation determined that 0.14% of the identified lots 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 in an incorrectly high patient result.

Context

GovInfoNow's records show Diasorin Inc. has had three other recalls since July 17, 2020, including a December 13, 2023 recall for the LIAISON HSV-2 Test and two November 2020 recalls for the LIAISON 1-84 PTH Assay and Parvovirus B19 IgG EIA Kit. Other recent recalls of similar products include a November 3, 2025 Leaky Gut Test Product Recall and February 16, 2026 ConvaTec EsteemBody Drainable Pouch Recalls.

How to tell if you have this one

Check for the product name 'LIAISON Q.S.E.T. Device Plus' with reference number 319060. Affected units include specific lot numbers listed in the recall notice for stool specimen preparation.

Brand
Diasorin
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the 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 on the device.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

Nov 7, 2024Firm started the recall
Dec 12, 2024FDA classified it Class II
Dec 18, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this device?

Check the lot number on your device. If it matches the listed numbers, stop using it and contact Diasorin for further instructions.

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Link to this recall

<a href="https://govinfonow.com/recall/53539-diasorin-liaison-q-s-e-t-device-plus-leaking-caps">Diasorin LIAISON Q.S.E.T. Device Plus: Leaking Caps Risk Incorrect Stool Test Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0677-2025 (November 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0677-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.