CLASS II Device recall · Reported 26 Jan 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 16 Apr 2021 and the FDA has classified it as Class II.
Check your package
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-0498-2022
- FDA event ID
- 89303
- Recalling firm
- Luminex, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2021
- FDA classified
- 14 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Apr 2021 | Recall initiated by company | |
| 14 Jan 2022 | Classified by FDA | +273 days |
| 26 Jan 2022 | Published in enforcement report | +12 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.
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, Part Number/REF 50-10017
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
Nationwide AlabamaCaliforniaGeorgiaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNebraskaNew JerseyNew MexicoOhioOklahomaOregonPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Impacted lot may leak inside the ARIES instrument.
Which lots are affected?
Lot number AB1703A
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
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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