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Beckman Coulter Chemistry Analyzers (2013-09-11)
- Starting date:
- September 11, 2013
- Posting date:
- September 27, 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-35895
Recalled products
- Beckman Coulter AU5400 Chemistry Analyzer
- Beckman Coulter AU2700 Chemistry Analyzer
- Beckman Coulter AU400 Chemistry Analyzer
- Beckman Coulter AU640 Chemistry Analyzer
- Beckman Coulter AU680 Chemistry Analyzer
- Beckman Coulter AU480 Chemistry Analyzer
- Beckman Coulter AU5800 Chemistry Analyzer
Reason
Beckman Coulter has confirmed that some AU clinical chemistry analyzer ISE units can experience premature ISE Ref (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE Ref solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
Affected products
A. Beckman Coulter AU5400 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU5400
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Beckman Coulter AU2700 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU2700
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Beckman Coulter AU400 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU400
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. Beckman Coulter AU640 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU640
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E Beckman Coulter AU680 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU680
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
F. Beckman Coulter AU480 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU480
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
G. Beckman Coulter AU5800 Chemistry Analyzer
Lot or serial number
All lots
Model or catalog number
- AU5810
- AU5820
- AU5830
- AU5840
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES