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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Diasorin LIAISON Q.S.E.T. Device Plus Recalled for Leaking and Testing Errors

Agency Publication Date: December 12, 2024
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Summary

Diasorin Inc. is recalling 21,905 units of the LIAISON Q.S.E.T. Device Plus because some devices may have loose clear caps that allow liquid buffer to leak from the tube. These devices are used in laboratories to prepare stool specimens for medical testing. If a device leaks, there may not be enough buffer left to prepare the sample correctly, which could result in an inaccurately high test result for a patient. There have been no reported injuries or incidents associated with this issue.

Risk

A leaking tube leads to insufficient buffer volume when preparing a specimen. This defect can cause the diagnostic equipment to produce an incorrectly high test result, potentially leading to a misdiagnosis or incorrect medical treatment for the patient.

What You Should Do

  1. This recall involves the DiaSorin LIAISON Q.S.E.T. Device Plus (REF 319060), which is a tool used by laboratories to prepare human stool specimens for diagnostic testing.
  2. Check your laboratory inventory for the product UDI/DI 80567713190605F and the specific affected lot numbers. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately to prevent potential testing errors.
  4. Contact Diasorin Inc. or your authorized medical distributor to arrange for a return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DiaSorin LIAISON Q.S.E.T. Device Plus
Model / REF:
319060
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
UDI:
80567713190605F

Intended for use in the preparation of human stool specimens.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95829
Status: Active
Manufacturer: Diasorin Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 21905 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.