Class II — Diasorin Inc.
| Recalling firm | DiaSorin Inc. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 |
| Quantity | 31992 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Initiated | 2023-12-13 |
| Classified | 2024-01-25 |
| Recall number | Z-0815-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diasorin Inc. (Z-0815-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93741/
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