Luminex recalls ARIES Flu A/B & RSV Assay (REF 50-10020) due to potential partial seal in side cassette assemblies 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 certain ARIES Flu A/B & RSV Assay kits because a portion of their side cassette assemblies may have a partial seal. This could lead to less accurate test results or unstable assays. If you own one of the affected lots, stop using it immediately.
The side cassette assemblies (SCAs) in some units have a partial seal on the back side. This partial seal may cause the assay to have less solution volume, leading to decreased sensitivity or stability in test results.
Users of the ARIES Flu A/B & RSV Assay kits with specific lot numbers (AA7127, AA7206, AA7312, AA7549, AA7635) are affected. Laboratory staff and healthcare professionals using these kits for testing are most at risk.
Check the lot number on the product label. Affected lots include AA7127 (immediately), AA7206 (immediately), AA7312 (by March 5, 2019), AA7549 (by March 30, 2019), and AA7635 (by April 10, 2019).
Look for the lot number on the product label to determine if it's affected.
If your lot number is AA7127 or AA7206, stop using the product immediately.
For other affected lots, stop using the product by the specified date (e.g., March 5, 2019 for AA7312).
Luminex is recalling certain ARIES Flu A/B & RSV Assay kits with specific lot numbers due to potential partial seals in side cassette assemblies that could affect test accuracy.
Affected lots include AA7127, AA7206, AA7312, AA7549, and AA7635 with specific discontinuation dates.
The partial seal may cause less solution volume in the assay, leading to decreased sensitivity or stability of the test results.
The recall does not mention a return process; affected units should be discontinued as per the specified dates.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2284-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2284-2019 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.
