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Open, Classified

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

FDA Recall Z-0815-2024 · Posted 2024-01-25

Recalling FirmDiasorin Inc.
Recall StatusOpen, Classified
Product CodeMYF
Date Initiated2023-12-13
Product Quantity31992 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081687LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGGDiaSorin, Inc. · 2008-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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