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Unicel DXC 600, 600I, and 800 Synchron Access Clinical Analyzers (2014-04-23)
- Starting date:
- April 23, 2014
- Posting date:
- May 8, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39395
Recalled Products
A. Unicel DXC 600
B. Unicel DXC 800
C. Unicel DXC 600I Synchron Access Clinical Analyzer
D. Unicel DXC 880I Synchron Access Clinical Analyzer
E. Unicel DXC 660I Synchron Access Clinical Analyzer
Reason
Beckman Coulter has identified a manufacturing issue with the no foam bottle assembly in the Unicel DXC Synchron Clinical systems and Unicel DXC Synchron Access Integrated Clinical systems which may cause the no foam solution to leak.
Affected products
A. Unicel DXC 600
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
4764
A11816
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Unicel DXC 800
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
4764
A10405
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Unicel DXC 600I Synchron Access Clinical Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
4767
A27318
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. Unicel DXC 880I Synchron Access Clinical Analyzer
Lot or serial number
2788
3563
4143
4282
Model or catalog number
4768
A59102
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. Unicel DXC 660I Synchron Access Clinical Analyzer
Lot or serial number
5911
6006
6012
6093
Model or catalog number
4771
A64871
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES