FDA recall Z-0815-2024

Product

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

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2023-12-13

Report date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stillwater, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0815-2024