Luminex recalls ARIES C. difficile Assay (REF 50-10018) due to potential partial seal in side cassette assemblies, which may decrease assay sensitivity or stability. Affected units include specific lot numbers with discontinue dates.
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 certain ARIES C. difficile Assay kits because a portion of the side cassette assemblies may have a partial seal. This could lead to less accurate test results or unstable testing. Affected units have specific lot numbers and discontinue dates.
The side cassette assemblies (SCAs) in some units have a partial seal on the back side. This partial seal might cause less solution volume in the assay, leading to less sensitive or unstable test results.
Users of the ARIES C. difficile Assay kits with lot numbers AA7306, AA7311, AA7627, or AA7634 are affected. Healthcare professionals and labs using these kits are most at risk.
Check the lot number on the ARIES C. difficile Assay kit. Affected lots are AA7306 (immediately), AA7311 (by Feb 27, 2019), AA7627 (by Mar 28, 2019), and AA7634 (by Apr 3, 2019).
Look for the lot number on the ARIES C. difficile Assay kit to determine if it is affected.
Stop using the kit immediately if it is lot AA7306, or by the specified date for other lots.
Luminex discovered that some side cassette assemblies have a partial seal, which could lead to less accurate test results or unstable testing.
Affected lots are AA7306 (immediately), AA7311 (by Feb 27, 2019), AA7627 (by Mar 28, 2019), and AA7634 (by Apr 3, 2019).
Discontinue use immediately for lot AA7306, or by the specified date for other lots.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2287-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2287-2019 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.
