Luminex recalls ARIES Group A Strep Assay (REF 50-10041) due to partial seal in side cassette assemblies potentially causing assay inaccuracies. Affected units include specific lot numbers with discontinuation 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 Group A Strep Assay kits with a partial seal in side cassette assemblies. This could lead to reduced solution volume and less accurate test results. Affected units have specific lot numbers and discontinuation dates.
The side cassette assemblies (SCAs) have a partial seal that may cause reduced solution volume. This can lead to decreased sensitivity or stability of the assay, potentially causing inaccurate test results.
Users of ARIES Group A Strep Assay kits with lot numbers AA7313 through AA7645 are affected. Laboratory personnel and healthcare providers using these kits are most at risk.
Check the lot number on the product label. Affected units include specific lot numbers: AA7313, AA7526, AA7605, AA7631, and AA7645 with discontinuation dates.
Identify the lot number on the product label to determine if it is affected.
Stop using the affected lot numbers immediately as per the discontinuation dates.
Luminex is recalling ARIES Group A Strep Assay kits with lot numbers AA7313 through AA7645.
The side cassette assemblies have a partial seal that may cause reduced solution volume and decreased sensitivity or stability of the assay.
Check the lot number on the product label. Affected units include specific lot numbers: AA7313, AA7526, AA7605, AA7631, and AA7645.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2286-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2286-2019 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.
