ARIES and ARIES M1 System (2018-07-02)
- Starting date:
- July 2, 2018
- Posting date:
- July 13, 2018
- 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-67228
Affected products
- ARIES System
- ARIES M1 System
Reason
A potential discrepancy in the firmware for a subset of ARIES System Barcode Scanners (CN-0321-01). When the potentially affected barcode scanner is used on multiple ARIES Cassettes at the same time, the system may prepopulate the "sample id" field with a previously stored sample id.
Affected products
A. ARIES System
Lot or serial number
All lots shipped from April 1, 2017 to June 14, 2018, contact manufacturer.
Model or catalog number
ARIES-M12V1-IVD
ARIES-M6V1-IVD
Companies
- Manufacturer
-
Luminex Corporation
12212 Technology Blvd
Austin
78727
Texas
UNITED STATES
B. ARIES M1 System
Lot or serial number
All lots shipped from April 1, 2017 to June 14, 2018, contact manufacturer.
Model or catalog number
ARIES-M12V1-IVD
ARIES-M6V1-IVD
Companies
- Manufacturer
-
Luminex Corporation
12212 Technology Blvd
Austin
78727
Texas
UNITED STATES