DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
FDA Recall #Z-0815-2024 — Class II — December 13, 2023
Product Description
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
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.
Recalling Firm
Diasorin Inc. — Stillwater, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
31992 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated