The Recall Desk
HighFDA (Devices)·Z-2287-2019·Announced 2019-08-21

Luminex Recalls ARIES C. difficile Assay Due to Seal Defects

Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.

What this means for you

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 is classified as FDA Class II. The hazard involves decreased assay sensitivity and stability, which poses a risk of inaccurate diagnostic results (false negatives/positives) for a high-risk pathogen (C. difficile), but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Luminex Corporation is recalling the ARIES C. difficile Assay (REF 50-10018, UDI # 00840487100059) 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 units.

The defect may cause a decrease in the volume of each solution within the SCAs, which could lead to decreased sensitivity or stability of the assay. The recall covers specific lot numbers with designated discontinue use dates: AA7306 (immediately), AA7311 (2/27/2019), AA7627 (3/28/2019), and AA7634 (4/3/2019).

The affected products were distributed in the United States and in Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom. Users should check their lot numbers against the list provided and discontinue use of the affected units according to the specified dates.

The recalled product

Product
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
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 (3)

  • AA7311 - 2/27/2019
  • AA7627 - 3/28/2019
  • AA7634 - 4/3/2019

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 →

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