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Unicel Clinical Analyzers and Immunoassay Systems
- Starting date:
- May 1, 2010
- Posting date:
- February 4, 2013
- 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-17233
Recalled Products
- Unicel DXC 660i Synchron Access Clinical Analyzer
- Unicel DXC 860i Synchron Access Clinical Analyzer
- Unicel DXC 880i Synchron Access Clinical Analyzer
- Unicel DXI 600 Access Immunoassay System – Instrument with Dual Gantry Class 2
- Unicel DXI 600 Access Immunoassay System – Instrument with Dual Gantry Class 3
- Unicel DXI 600 Access Immunoassay System
- Unicel DXI 600 Access Immunoassay System – Instrument Class 3
- Unicel DXI 600 Access Immunoassay System – Instrument Class II
- Unicel DXI 800 Access Immunoassay - Analyzer – Class 3
- Unicel DXI 800 Access Immunoassay System
- Unicel DXI 800 Access - Analyzer – Class II
Reason
As a part of the 10,000-Test Maintenance Procedure, which occurs on average once a month in the DXI family of instruments, customers are required to replace aspirate and dispense probes and tubing. The dispense and aspirate tubing can become pinched or damaged as a result of incorrect customer installation of the tubing after probe maintenance or replacement, which may prevent the DXI and DXC Systems from washing reaction vessels properly and may lead to erroneous test results.
Affected products
A. Unicel DXC 660i Synchron Access Clinical Analyzer
Lot or serial number
- 900227
- 900228
- 900241
- 900304
- 900330
- 900334
- 900363
- 900403
Model or catalog number
A30260
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Unicel DXC 860i Synchron Access Clinical Analyzer
Lot or serial number
- 900227
- 900228
- 900241
- 900304
- 900330
- 900334
- 900363
- 900403
Model or catalog number
A30260
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Unicel DXC 880i Synchron Access Clinical Analyzer
Lot or serial number
- 600785
- 601704
- 601705
- 601746
Model or catalog number
- 4768
- A59102
Companies
- Manufacturer
- Beckman Coulter Inc.
D. Unicel DXI 600 Access Immunoassay System - Instrument with Dual Gantry Class 2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
973100
E. Unicel DXI 600 Access Immunoassay System - Instrument with Dual Gantry Class 3
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
973100
Companies
- Manufacturer
- Beckman Coulter Inc.
F. Unicel DXI 600 Access Immunoassay System
Lot or serial number
- 900227
- 900228
- 900330
Model or catalog number
- 4771
- A64871
Companies
- Manufacturer
- Beckman Coulter Inc.
G. Unicel DXI 600 Access Immunoassay System - Instrument Class 3
Lot or serial number
900359
Model or catalog number
- 4773
- A64935
Companies
- Manufacturer
- Beckman Coulter Inc.
H. Unicel DXI 600 Access Immunoassay System - Instrument Class II
Lot or serial number
900359
Model or catalog number
A71461
Companies
- Manufacturer
- Beckman Coulter Inc.
I. Unicel DXI 800 Access Immunoassay - Analyzer - Class 3
Lot or serial number
900359
Model or catalog number
A71461
Companies
- Manufacturer
- Beckman Coulter Inc.
J. Unicel DXI 800 Access Immunoassay System
Lot or serial number
- 900227
- 900228
- 900241
- 900304
- 900330
- 900334
- 900363
- 900403
Model or catalog number
A30260
Companies
- Manufacturer
- Beckman Coulter Inc.
K. Unicel DXI 800 Access - Analyzer - Class II
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
973100
Companies
- Manufacturer
- Beckman Coulter Inc.