Luminex recalls Aries Bordetella Assay (REF 50-10037) due to partial seal in side cassette assemblies potentially causing assay inaccuracies. Affected units include specific lot numbers with immediate discontinuation needed.
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 Bordetella Assay kits because a part of the cassette assembly may not seal properly. This could lead to less accurate test results. Affected units have specific lot numbers that must be stopped using immediately.
The side cassette assemblies (SCAs) in some units have a partial seal that may cause less solution volume and reduced sensitivity or stability in the test. This could lead to inaccurate test results but does not pose a direct physical hazard.
Users of the Aries Bordetella Assay kits with lot numbers AA7125, AA7310, AA7548, or AA7633 are affected. Laboratory staff and healthcare professionals using these kits for Bordetella testing are most at risk.
Check the lot number on the Aries Bordetella Assay kit (REF 50-10037). Affected lots include AA7125, AA7310, AA7548, and AA7633. Discontinue use immediately for these specific lots.
Discontinue use of Aries Bordetella Assay kits with lot numbers AA7125, AA7310, AA7548, or AA7633.
Affected lots are AA7125, AA7310, AA7548, and AA7633.
Discontinue use immediately and do not use the affected lots.
The recall does not mention a fix; affected kits must be stopped using immediately.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2282-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2282-2019 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.
