Class II

Medical Device Recall: DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Diasorin Inc. · December 13, 2023

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

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

31992 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0815-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.