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Class 2 Device Recall DiaSorin LIAISON |
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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
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Product Classification |
Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 - Product Code MYF
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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
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For Additional Information Contact |
651-439-9710
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MYF and Original Applicant = DIASORIN, INC.
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