The Recall Desk
ModerateFDA (Devices)·Z-2283-2019·Announced 2019-08-21

Luminex ARIES HSV 1&2 Assay Recalled for Seal Defects

Luminex is recalling ARIES HSV 1&2 Assay kits because side cassette seals did 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, and the source text describes a potential decrease in assay sensitivity or stability without reporting specific adverse health consequences or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Luminex Corporation is recalling the ARIES HSV 1&2 Assay (REF 50-10017, UDI # 00840487100295) due to a manufacturing defect. An internal investigation revealed that a portion of the side cassette assemblies (SCAs) had back side seals (BSS) that did not meet design specifications, resulting in partially sealed SCAs.

The impact of these partial seals could result in a potential decrease of volume for each solution in the SCAs, which may lead to decreased sensitivity or stability of the assay. The recall covers specific lot numbers with designated discontinue use dates, including AA7308, AA7485, AA7545, AA7625, AA7630, AA7636, AA7945, and AA7985.

The affected products were distributed in the United States and internationally to Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom. Users should check their inventory for the affected lot numbers and discontinue use according to the specified dates.

The recalled product

Product
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Manufacturer
Luminex Corporation
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (7)

  • AA7485 - 2/23/2019
  • AA7545 - 3/13/2019
  • AA7625 - 4/10/2019
  • AA7630 - 3/16/2019
  • AA7636 - 4/3/2019
  • AA7945 - 4/25/2019
  • AA7985 - 5/8/2019

Distribution

Distributed in 34 states:

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.

See all 7 products in this recall →

Related recalls

Same manufacturer · Luminex Corporation

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Same hazard · defective seal

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