FDA Medical Device Recalls (openFDA)
Diasorin Inc.: DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- Recall number
- Z-0815-2024
- Recalling firm
- Diasorin Inc.
- Product
- DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- Status
- Open, Classified
- Initiated
- 2023-12-13
- Posted
- 2024-01-25
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 31992 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775
- 510(k) numbers
- ["K081687"]
- PMA numbers
- not on file
- Product code
- MYF
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28