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
Affected Products
- ARIES Flu A/B and RSV Assay
- 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
-
ARIES Flu A/B and RSV Assay
Lot or serial number
AA7127
AA7206
AA7312
AA7549
AA7635
Model or catalog number
50-10020
Companies
- Manufacturer
-
Luminex Corporation
12212 Technology Blvd
Austin
78727
Texas
UNITED STATES
B. ARIES Extraction Kit
Lot or serial number
AA7126
AA7307
AA7385
AA7525
AA7547
AA7628
AA7666
Model or catalog number
50-10026
Companies
- Manufacturer
-
Luminex Corporation
12212 Technology Blvd
Austin
78727
Texas
UNITED STATES