Luminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects
Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to decreased assay sensitivity or stability, posing a risk of harm through inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Luminex Corporation is recalling the ARIES Flu A/B & RSV Assay (REF 50-10020) due to a manufacturing defect. 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 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 by dates, including AA7127, AA7206, AA7312, AA7549, and AA7635.
The affected products were distributed in the United States and internationally, including in Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom. Users should check their lot numbers against the recall list and discontinue use of the affected units immediately or by the specified dates.
The recalled product
- Product
- ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
- 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)
- AA7206 - Immediately
- AA7312 - 3/5/2019
- AA7549 - 3/30/2019
- AA7635 - 4/10/2019
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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