Luminex recalls ARIES HSV 1&2 Assay (REF 50-10017) due to potential partial sealing of side cassette assemblies, which may decrease solution volume and assay sensitivity. 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 its ARIES HSV 1&2 Assay (REF 50-10017) because some side cassette assemblies have a partial seal that could reduce solution volume and make the assay less sensitive. This recall affects specific lot numbers with different discontinuation dates.
The side cassette assemblies (SCAs) 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 pose a direct physical risk like injury or fire.
Users of the ARIES HSV 1&2 Assay who have the affected lot numbers (AA7308 through AA7985) are most at risk. The recall targets laboratory or clinical settings using this assay.
Check the lot number on the product label. Affected lots are AA7308, AA7485, AA7545, AA7625, AA7630, AA7636, AA7945, and AA7985. Discontinue use by the dates listed for each lot.
Identify the lot number on the product label to determine if it is affected.
Stop using the affected lot numbers by the specified discontinuation dates.
The side cassette assemblies (SCAs) have a partial seal that may reduce solution volume and decrease assay sensitivity.
Affected lot numbers are AA7308, AA7485, AA7545, AA7625, AA7630, AA7636, AA7945, and AA7985.
Discontinue use by the dates listed for each lot: AA7308 immediately, AA7485 by 2/23/2019, AA7545 by 3/13/2019, AA7625 by 4/10/2019, AA7630 by 3/16/2019, AA7636 by 4/3/2019, AA7945 by 4/25/2019, and AA7985 by 5/8/2019.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2283-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2283-2019 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.
