FDAFDA · Food and drugs·Recall number Z-0815-2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Published January 31, 2024 · Recall initiated: December 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Diasorin Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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