Recall Z-0815-2024
Diasorin Inc. · initiated December 13, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Codes / lots: UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
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.
FDA-determined cause: Under Investigation by firm
Action taken
DiaSorin issued a DIASORIN CUSTOMER NOTIFICATION LETTER to its consignees on 12/13/2023 via email. The notice explained the issue, risk to health, and requested the disposal of all affected inventory. The firm will be providing replacement kits.
Details
- Recall number
- Z-0815-2024
- Initiated
- December 13, 2023
- Posted by FDA
- January 25, 2024
- Product code
- MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Quantity
- 31992 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Diasorin Inc., Stillwater, MN