ARIES Flu and RSV Assay, Extraction Kit (2019-02-12)

Starting date:

February 12, 2019

Posting date:

March 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69192

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  Reason
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  Affected products

Affected Products

1. ARIES Flu A/B and RSV Assay
2. ARIES Extraction Kit

Reason

Luminex recently identified a manufacturing defect. An internal investigation identified a defect in the back seal that affects a portion of cassettes manufactured between 9/18/2018 and 1/15/2019.  The back seal plays a role in maintaining performance until the labeled expiration date.  The investigation has concluded performance of the lots listed meet performance claims at this time.  However, it is possible that the seal performance may not be maintained throughout the shelf life provided in the product labeling.  The identified defect has a remote possibility of leading to an invalid or false negative result when using the affected aries assay lots.

Affected products