Luminex recalls ARIES Extraction Kit and ARIES System with partial seal in side cassette assemblies that may cause reduced solution volume and assay instability. Affected units include specific lot numbers with deadlines for discontinuation.
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Luminex is recalling ARIES Extraction Kit and ARIES System products due to side cassette assemblies with partial seals that could lead to reduced solution volume and less stable test results. This issue affects specific lot numbers and requires stopping use by certain dates.
A partial seal in the side cassette assemblies can cause less solution to be held and make test results less reliable. This may lead to inaccurate assay outcomes but does not pose a direct physical danger like injury or fire.
Users of Luminex ARIES Extraction Kit and ARIES System products with affected lot numbers are most at risk. The recall targets laboratory or clinical settings using these devices for testing.
Check the lot number on the product label. Affected units include specific lot numbers: AA7126, AA7307, AA7385, AA7525, AA7547, AA7628, and AA7666. Discontinue use by the dates listed for each lot.
Look for the lot number on the product label to determine if it is affected.
Stop using the product immediately if the lot number is listed as affected.
The side cassette assemblies have a partial seal that may cause reduced solution volume and decreased sensitivity or stability of the assay.
Affected lot numbers include AA7126, AA7307, AA7385, AA7525, AA7547, AA7628, and AA7666.
Discontinue use immediately for lot numbers AA7126, AA7307, AA7385, and AA7525. Other lots have specific deadlines: AA7547 by March 16, 2019; AA7628 by April 12, 2019; AA7666 by March 28, 2019.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2288-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2288-2019 from Luminex. 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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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.
