LIAISON® HSV-2 Type Specific IgG 310620Recalls & reported problems
Diasorin Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This DiaSorin LIAISON HSV-2 test is a lab test that checks blood for antibodies to herpes simplex virus type 2. The 26 reports describe the test showing positive results that later follow-up testing did not confirm, with no deaths and 25 injuries mentioned. There is 1 open recall started in December 2023 because some lots may give more unclear or false positive results. Reports rose to 25 in the last 12 months from 0 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08056771600101), received between Aug 8, 2024 and Mar 4, 2026 — classified as 25 injuries, 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (26 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 13, 2023Class IIOpen, Classified
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.
Z-0815-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result26
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Anxiety1
- Depression1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508486 ↗InjuryMar 4, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508478 ↗InjuryMar 4, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508476 ↗InjuryMar 4, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508465 ↗InjuryMar 4, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508462 ↗InjuryFeb 6, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280020 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279961 ↗InjuryFeb 6, 2026False Positive Result
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. . NO ADVERSE CLINICAL OUTCOMES WERE REPORTED. CONFIRMATORY TEST (TEST TYPE AND SITE UNKNOWN) WAS NEGATIVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279957 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279952 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST SITE UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279905 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST SITE UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279871 ↗InjuryFeb 6, 2026False Positive Result
UNIVERSITY OF WASHINGTON WESTERN BLOT TEST DATE (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279869 ↗InjuryFeb 6, 2026False Positive Result
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. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED. CONFIRMATORY TEST (TEST TYPE AND SITE UNKNOWN) WAS NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279868 ↗InjuryFeb 6, 2026False Positive Result
(B)(6) BLOT TEST DATE (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279862 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279857 ↗InjuryFeb 6, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279838 ↗InjuryFeb 6, 2026False Positive Result
(B)(6) TEST DATE (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279837 ↗InjuryFeb 6, 2026False Positive Result
UNIVERSITY OF WASHINGTON WESTERN BLOT TEST DATE (B)(6) 2024
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279802 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279778 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279733 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279617 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279614 ↗InjuryFeb 6, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279612 ↗InjuryFeb 6, 2026False Positive Result
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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279607 ↗InjuryFeb 6, 2026False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279100 ↗
Other Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 devices
- Elecsys HSV2 IgG Immunoassay 5572193160Roche Diagnostics GmbH · Enzyme linked immunosorbent assay, herpes simplex virus, hsv-21 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page