DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Summary
The FDA issued a Class II for DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the prepa by Diasorin Inc.. Reason: Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of .
Details
Source
Device Recall
External ID
Z-0677-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Lot/Code Info: 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
Quantity Affected: 21905 units
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.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-07
Company
Stillwater, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diasorin Inc. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diasorin Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diasorin Inc. have FDA actions?
Diasorin Inc. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0677-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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