Recall Z-0815-2024 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Diasorin Inc.
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
| Date | Jan 25, 2024 (initiated Dec 13, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 31992 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DiaSorin, Inc., Nov 10, 2008 |