ICHEM Velocity Automated Urine Chemistry Systems (2019-10-23)
- Starting date:
- October 23, 2019
- Posting date:
- November 29, 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-71714
Last updated: 2019-12-02
Affected Products
A. ICHEM Velocity Automated Urine Chemistry System
B. ICHEM Velocity Automated Urine Chemistry System W Load/Unload
C. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED
D. IQ 200 Elite Plus
E. IQ 200 Elite Pro
F. IQ 200 Select Pro
G. IQ 200 Select Plus
H. IQ 200 Sprint Pro
I. IQ 200 Sprint Pro W Load/Unload
J. IQ 200 Sprint Plus
K. IQ 200 Sprint Plus W Load/Unload
Reason
Customers have reported incidents where two sets of results report the ame specimen identifier (specimen ID) with different results, different medical record number (MRN) and different patient identification (demographics).
Affected products
A. ICHEM Velocity Automated Urine Chemistry System
Lot or serial number
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
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
All lots.
Model or catalog number
800-3081
Companies
- Manufacturer
-
Beckman Coulter Ireland, Inc.
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND