Luminex ARIES Extraction Kit Recalled for Partially Sealed Cassette Assemblies
Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves decreased assay sensitivity or stability without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Luminex Corporation is recalling the ARIES Extraction Kit, ARIES System, and SYNCT (REF 50-10026, UDI # 00840487100073). The recall was initiated after an internal investigation revealed that a portion of the side cassette assemblies (SCAs) had a back side seal (BSS) that did not meet design specifications, resulting in partially sealed SCAs.
The impact of a partial seal in the BSS could result in a potential decrease of volume for each solution in the SCAs. This defect may lead to decreased sensitivity or stability of the assay. The affected products were distributed in the United States and in Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom.
Users should discontinue use of the affected lot numbers immediately or by the specified dates. The affected lot numbers for Part Number 50-10026 are AA7126, AA7307, AA7385, AA7525, AA7547, AA7628, and AA7666. Specific discontinue use dates range from immediately to April 12, 2019.
The recalled product
- Product
- ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
- Manufacturer
- Luminex Corporation
Distribution
Part of a larger recall action
This product is one of 7 recalled by Luminex Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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