iChemVELOCITY Automated Urine Chemistry System - with Load/Unload and Back Integrated, iRICELL1000 Plus, iRICELL2000 Plus and Pro, iRICELL3000 Plus and Pro (2018-02-26)
- Starting date:
- February 26, 2018
- Posting date:
- April 3, 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-66318
Affected products
- iChemVELOCITY Automated Urine Chemistry System
- ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
- ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED
- IRICELL 2000 PRO
- IRICELL 2000 PLUS
- IRICELL 3000 PLUS
- IRICELL 3000 PRO
- IRICELL 1000 PLUS
Reason
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers.
- The installation of international settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations.
- The installation of colors different from those stated in the instructions for use (colorless, straw, yellow, amber, red, blue) for output settings will result in incorrect reporting of colors. For example, if green is the color choice for the output setting instead of blue, green will be reported.
Affected products
-
iChemVELOCITY Automated Urine Chemistry System
Lot or serial number
All lots.
Model or catalog number
800-7719
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
Lot or serial number
All lots.
Model or catalog number
800-7167
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED
Lot or serial number
All lots.
Model or catalog number
800-7720
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
D. IRICELL 2000 PRO
Lot or serial number
All lots.
Model or catalog number
800-3049
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
E. IRICELL 2000 PLUS
Lot or serial number
All lots.
Model or catalog number
800-7714
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
F. IRICELL 3000 PLUS
Lot or serial number
All lots.
Model or catalog number
800-3079
800-7713
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
G. IRICELL 3000 PRO
Lot or serial number
All lots.
Model or catalog number
800-3050
800-3080
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
H. IRICELL 1000 PLUS
Lot or serial number
All lots.
Model or catalog number
800-7715
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES