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U.S. Department of Health and Human Services

Class 2 Device Recall DiaSorin LIAISON

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 Class 2 Device Recall DiaSorin LIAISONsee related information
Date Initiated by FirmNovember 07, 2024
Date PostedDecember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0677-2025
Recall Event ID 95829
510(K)NumberK213858 
Product Classification Calprotectin, fecal - Product Code NXO
ProductDiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Code Information 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
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactJohn Walter
651-439-6710
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionDiaSorn 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); productsupport@diasorin.com
Quantity in Commerce21905 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NXO
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