Luminex ARIES Group A Strep Assay Recalled for Seal Defects
Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test 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, but the source text describes a theoretical risk of decreased sensitivity or stability without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Luminex Corporation is recalling the ARIES Group A Strep Assay (REF 50-10041) due to a manufacturing defect discovered during an internal investigation. The defect involves side cassette assemblies (SCAs) where the back side seal (BSS) did not meet design specifications, resulting in partially sealed units.
The impact of this partial seal could result in a potential decrease in the volume of each solution within the SCAs. This may lead to decreased sensitivity or stability of the assay. The recall affects specific lot numbers with designated discontinue use dates, including AA7313 (immediately), AA7526 (3/7/2019), AA7605 (3/9/2019), AA7631 (4/3/2019), and AA7645 (4/12/2019).
The product was distributed in the United States and internationally, including Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom. Users should check their lot numbers against the list provided by the manufacturer and discontinue use of affected units according to the specified dates.
The recalled product
- Product
- ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
- Manufacturer
- Luminex Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- AA7526 - 3/7/2019
- AA7605 - 3/9/2019
- AA7631 - 4/3/2019
- AA7645 - 4/12/2019
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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