FDA Device recall Z-0815-2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 by Diasorin, citing diaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Speci….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0815-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-13 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diasorin |
| Distribution | US |
Product
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
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.
Identifiers
| code_info | UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2024%22
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