DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 recallZ-0815-2024 · Diasorin Inc. · initiated Dec 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diasorin Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0815-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 13, 2023
- Posted by the FDA
- Jan 25, 2024
- Recalling firm
- Diasorin Inc.
- Quantity
- 31992 units
- Product code
- MYF
- FDA submissions
- K081687
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Code information (models, lots, serial numbers)
UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LIAISON® HSV-2 Type Specific IgG 310620Diasorin Inc. · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-21 recall26 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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