MAUDE Adverse Event Report: DIASORIN INC. LIAISON HSV-2 TYPE SPECIFIC IGG; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Catalog Number	310620
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the information reasonably known at the time of reporting indicates that no death or patient injury, illness, life threatening condition, permanent impairment, permanent damage to a body structure, or medical or surgical intervention to prevent permanent impairment or damage occurred (definition of serious injury 21 cfr 803.3).The manufacturer previously identified a device performance issue associated with increased equivocal and false positive hsv-2 igg results affecting a subset of product lots manufactured prior to december 2023.Corrective actions were implemented through the capa system, and a class ii recall was initiated on december 13, 2023 to remove and replace affected lots.The lot number associated with this event is unknown.Because the reported event date may overlap with the period during which recalled lots remained in distribution, involvement of an affected lot cannot be definitively ruled out.While recurrence of this issue is unlikely to result in death or serious injury, this report is being conservatively submitted.
Event or Problem Description
Diasorin received a voluntary medwatch report alleging a false positive result generated by the diasorin liaison® xl hsv 2 igg assay performed by an external laboratory.According to the report, the patient tested positive by the liaison® xl hsv-2 type specific igg assay and positive by the external laboratory's inhibition assay.Confirmatory test (test type and site unknown) was negative.No adverse clinical outcomes were reported.
Event or Problem Description
Confirmatory test, (b)(6).Lot test date: 09/06/2023.

• Brand Name: LIAISON HSV-2 TYPE SPECIFIC IGG
• Common Device Name: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): DIASORIN INC.; 1951 northwestern ave; stillwater MN 55082 0285
• Manufacturer (Section G): DIASORIN INC.; 1951 northwestern ave; stillwater MN 55082 0285
• Manufacturer Contact: kym pieper ; 1951 northwestern ave.; stillwater, MN 55082-0285 ; 6514399710
• MDR Report Key: 24508465
• Report Number: 2182595-2026-00022
• Device Sequence Number: 13365988
• Product Code: MYF
• UDI-Device Identifier: 08056771600101
• UDI-Public: 08056771600101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 310620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0815-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male