ICHEM Velocity Automated Urine Chemistry System and IQ 200 System (2020-03-30)
- Starting date:
- March 30, 2020
- Posting date:
- April 17, 2020
- 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-72825
Last updated: 2020-04-17
Affected Products
- ICHEM Velocity Automated Urine Chemistry System
- ICHEM Velocity Automated Urine Chemistry System W Load/Unload
- ICHEM Velocity Automated Urine Chemistry System Back Integrated
- IQ 200 Elite Plus
- IQ 200 Elite Pro
- IQ 200 Select Pro
- IQ 200 Select Plus
- IQ 200 Sprint Pro
- IQ 200 Sprint Pro W Load/Unload
- IQ 200 Sprint Plus
- IQ 200 Sprint Plus W Load/Unload
Reason
Beckman Coulter has become aware of a manufacturing defect affecting an externally supplied serial advanced technology attachment (SATA) adapter cable. This cable is used internally in the personal computer version 6 (PC6) connected to the IQ200 and/or the ICHEMVelocity. The cable provides power to the optical CD drive in the computer. Instruments with these computers were installed between July 2012 and December 2014.
Affected products
A. ICHEM Velocity Automated Urine Chemistry System
Lot or serial number
V02198
V02199
V02304
V02362
V02564
V02610
V02629
V02632
V02702
Model or catalog number
800-7719
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
B. ICHEM Velocity Automated Urine Chemistry System W Load/Unload
Lot or serial number
V02198
V02199
V02304
V02362
V02564
V02610
V02629
V02632
V02702
Model or catalog number
800-7167
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
C. ICHEM Velocity Automated Urine Chemistry System Back Integrated
Lot or serial number
V02198
V02199
V02304
V02362
V02564
V02610
V02629
V02632
V02702
Model or catalog number
800-7720
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
D. IQ 200 Elite Plus
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3934
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
E. IQ 200 Elite Pro
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3052
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
F. IQ 200 Select Pro
Lot or serial number
6996
3999
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3051
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
G. IQ 200 Select Plus
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3935
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
H. IQ 200 Sprint Pro
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3053
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
I. IQ 200 Sprint Pro W Load/Unload
Lot or serial number
6996
7570
3999
7228
7230
7345
7579
7667
Model or catalog number
800-3082
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
J. IQ 200 Sprint Plus
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3933
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND
K. IQ 200 Sprint Plus W Load/Unload
Lot or serial number
3999
6996
7228
7230
7345
7570
7579
7667
Model or catalog number
800-3081
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND