DiaSorin LIAISON Device Recall: Loose Caps May Cause Incorrect Patient Test Results
DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall where the manufacturing defect (loose caps) poses a risk of harm through incorrect diagnostic results in a clinical laboratory context. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
DiaSorin Inc. is recalling the LIAISON Q.S.E.T. Device Plus (REF 319060), a medical device used in the preparation of human stool specimens for laboratory testing. Approximately 21,905 units distributed worldwide are affected.
Customer complaints reported that some devices were leaking and contained insufficient buffer volume. Following an investigation, Diasorin determined that approximately 0.14% of the recalled units have loose clear caps. These loose caps may allow buffer solution to leak from the tube, which could result in stool samples being prepared with less than the correct amount of buffer and lead to incorrectly high test results.
Healthcare facilities and laboratories using affected units should identify them by lot number and contact Diasorin Inc. for further instructions. The affected lot numbers are listed on the FDA recall notice (Z-0677-2025).
The recalled product
- Product
- DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
- Manufacturer
- Diasorin Inc.
- Affected units
- 21,905
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 80567713190605F
- Lot Numbers: 225084
- 232094
- 234114
- 259144
- 221214
- 252244
- 230094
- 224124
- 205144
- 228174
- 228224
- 223274
- 219104
- 217134
- 233154
- 236174
- 224244
- 232294
- 229224
Distribution
Distribution scope not specified by the agency.
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