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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 LIAISON see related information
Date Initiated by Firm December 13, 2023
Date Posted January 25, 2024
Recall Status1 Open3, Classified
Recall Number Z-0815-2024
Recall Event ID 93741
510(K)Number K081687  
Product Classification Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 - Product Code MYF
Product DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Code Information UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		 DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
FDA Determined
Cause 2		 Under Investigation by firm
Action DiaSorin issued a DIASORIN CUSTOMER NOTIFICATION LETTER to its consignees on 12/13/2023 via email. The notice explained the issue, risk to health, and requested the disposal of all affected inventory. The firm will be providing replacement kits.
Quantity in Commerce 31992 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MYF and Original Applicant = DIASORIN, INC.
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