ICHEM Velocity Automated Urine Chemistry System (2019-10-28)
- Starting date:
- October 28, 2019
- Posting date:
- April 15, 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-72711
Last updated: 2020-04-15
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
Reason
As a result of an internal investigation, Beckman Coulter has become aware of an issue affecting specific gravity chemistry settings for the ICHEM Velocity Urine Chemistry System that prevents the trigger of a chemistry system flag ""S3"" and may result in erroneous specific gravity (SG) results.
- The S3 value flag is generated when the instrument is unable to measure the specific gravity of the sample due to an interference in the sample or a hardware failure.
- The S3 value flag triggers chemistry system flags that are designed to require operator review prior to release of results.
- The ICHEMVelocity instructions for use (IFU) incorrectly states that for S3, ""the specific gravity result >1.060. This is a normal condition."" The IFU does not state that S3 value flag is generated when the instrument is unable to measure the specific gravity of the sample due to an interference in the sample or a hardware failure.
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