CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report

Aries HSV 1&2 Assay recalled by Luminex

Luminex is recalling Aries HSV 1&2 Assay, distributed nationwide in the US. The recall was initiated on 17 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers AB3600A and AB3560A

Quantity recalled329

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0553-2022
FDA event ID: 89244
Recalling firm: Luminex, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2021
FDA classified: 2 Feb 2022
Reported: 9 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

17 Nov 2021	Recall initiated by company
2 Feb 2022	Classified by FDA	+77 days
9 Feb 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.

Nationwide California Connecticut Minnesota Missouri New Jersey New Mexico Pennsylvania Tennessee Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers AB3600A and AB3560A

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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