DiaSorin LIAISON HSV-2 Type Specific IgG — Class II medical device recall Z-0815-2024
Ongoing recall by Diasorin Inc., reported 2024-01-31, distributed nationwide. DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604
| Recall number | Z-0815-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasorin Inc., Stillwater, MN, United States |
| Recall initiated | 2023-12-13 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 31,992 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 08056771600101 |
| Lot numbers | 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775 |
| Model numbers | 310620 |
Product
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0815-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.