DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- Company
- Diasorin Inc.
- Recall Initiated
- December 13, 2023
- Posted
- January 25, 2024
- Recall Number
- Z-0815-2024
- Quantity
- 31992 units
- Firm Location
- Stillwater, MN
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.
Lot / Code Info
UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
Root 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.