FDA-Device2024-01-31Class II

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Diasorin Inc.
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
31992 units
Manufactured in
1951 Northwestern Ave S, N/A, Stillwater, MN, United States
Products
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Official notice

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

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