Luminex recalls ARIES GBS Assay (REF 50-10021) due to potential partial sealing of side cassette assemblies, which may cause reduced solution volume and assay instability. 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 ARIES GBS Assay kits with part number 50-10021 because some side cassette assemblies have a partial seal that could lead to less solution volume and less accurate test results. This affects kits sold with specific lot numbers that need to be stopped using by certain dates.
The side cassette assemblies (SCAs) in some units have a partial seal that may cause less solution to be held in the cassette. This could lead to reduced sensitivity or stability of the assay results, but does not cause immediate harm to users.
Users of the ARIES GBS Assay kits with part number 50-10021 are affected. Those who have the specific lot numbers listed in the recall notice are most at risk.
Check the lot number on the ARIES GBS Assay kit (part number 50-10021). Affected units include lot numbers AA7546 (stop using by March 9, 2019) and AA7629 (stop using by April 10, 2019).
Discontinue use of the ARIES GBS Assay kit with part number 50-10021 and the specific lot numbers listed in the recall notice.
The side cassette assemblies (SCAs) in some units have a partial seal that may cause less solution volume and reduced assay sensitivity or stability.
Lot numbers AA7546 (stop using by March 9, 2019) and AA7629 (stop using by April 10, 2019).
The recall notice does not specify a return process, only a stop-use date for affected lots.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2285-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2285-2019 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.
