Z-0815-2024 Class II Ongoing

Recalled by Diasorin Inc. — Stillwater, MN

Recall Details

Product Type
Devices
Report Date
January 31, 2024
Initiation Date
December 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31992 units

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.

Distribution Pattern

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