Z-0815-2024Class II

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Name: Z-0815-2024 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Creator: Diasorin Inc.
Published: 2023-12-13
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2023-12-13 / Open, Classified

FDA source

Diasorin Inc. began a recall of DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 on 2023-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0815-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-13
Posted: 2024-01-25
Recalling firm: Diasorin Inc.
Product: DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Product code: MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 31992 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0815-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0815-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25

Product code MYF

K081687Class IILiaison Hsv-2 Type Specific Igg Assay, Control Hsv-2 IggDiaSorin, Inc. / cleared 2008-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)