Reported Feb 9, 2022 · Terminated

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

Luminex Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101

Is this the product you have?

    • ARIES HSV 1&2 Assay
    • Catalog/REF# 50-10017
Lot codes and dates
  • Lot Numbers AB3600A and AB3560A
Amount recalled
329

Where it was sold

Why it was recalled

Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2024 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.