DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
FDA device recall Z-0815-2024 · posted 2024-01-25 · Open, Classified
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MYF
- Quantity affected
- 31992 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2023-12-13
- Date posted
- 2024-01-25
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687) | DiaSorin, Inc. | 2008-11-10 |