Diasorin LIAISON HSV-2 Test May Give False Positives - Recall
Diasorin recalls specific lots of HSV-2 Type Specific IgG test kits that may produce false positive results. Affected lots include 136344 through 136775. No action needed for users but verify your lot number.
Lower-risk 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.
Contact the company
What happened, in plain English
Diasorin is recalling certain lots of HSV-2 Type Specific IgG test kits that may give false positive results. This could lead to incorrect diagnoses of herpes simplex virus type 2. No action is required for users but they should check their lot numbers. Read more at govinfonow.com/recall/56563-diasorin-liaison-hsv-2-test-may-give-false-positives-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/56563-diasorin-liaison-hsv-2-test-may-give-false-positives-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0815-2024
Cite this page
“Diasorin LIAISON HSV-2 Test May Give False Positives - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56563-diasorin-liaison-hsv-2-test-may-give-false-positives-recall. Based on FDA recall #Z-0815-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2024%22&limit=1).
Why it’s dangerous
The recalled test kits may produce increased equivocal or false positive results, meaning they could incorrectly indicate herpes simplex virus type 2 infection when none exists. This might lead to unnecessary anxiety or treatment decisions.
Who’s affected
People who use the DiaSorin LIAISON HSV-2 Type Specific IgG test kits with lot numbers 136344 through 136775. Those most at risk are individuals who rely on these tests for herpes diagnosis.
How to tell if you have this one
Check the lot number on your test kit, which should be one of 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, or 136775.
- Brand
Diasorin- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on your test kit, which should be one of the listed numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0815-2024 (December 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0815-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.