DiaSorin MOL2150 HSV Swabs Recall: False Negative Risk from Software Glitch

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Recalling firmDiaSorin Molecular LLC11331 Valley View St, N/A · Cypress, CA 90630-5366

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✎ GovInfoNow plain-language explainer

What happened, in plain English

DiaSorin is recalling MOL2150 HSV 1&2 swabs that may produce false negative results when used with their LIAISON MDX instrument. This could lead to incorrect test outcomes for herpes infections, especially in critical cases like CNS infections.

Why it’s dangerous

The swabs have a software glitch in the Multi Assay Suite that can cause false negative results. This means tests might show no herpes infection when it's actually present, especially in serious cases like central nervous system infections.

Who’s affected

Users of the MOL2150 swabs for herpes testing, particularly healthcare providers and labs handling cerebrospinal fluid or genital swabs. Patients with suspected CNS herpes infections are at higher risk of missing diagnosis.

How to tell if you have this one

Check the lot number on the swab packaging. Affected lots include 3606N through 5888N (with specific release dates and expiration dates listed in the recall notice).

Brand
DiaSorin
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the swab packaging to determine if it's affected. Affected lots range from 3606N to 5888N with specific release dates.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is due to a software malfunction in the Multi Assay Suite that increases the chance of false negative results for herpes tests.

What does false negative mean?

False negative means the test shows no herpes infection when it's actually present, which could lead to missed diagnoses.

Are there any safety risks?

The recall is for potential false negatives, not immediate physical harm. The risk is low and specific to test accuracy, not direct injury.

Take action

Contact DiaSorin

We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2547-2020 — DiaSorin DiaSorin

Hello,

I own a DiaSorin that is covered by recall Z-2547-2020 from DiaSorin.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2547-2020 (May 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2547-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

DiaSorin Molecular LLC recalls MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use

Lower-risk recall