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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

  1. Beckman Coulter AU5400 Chemistry Analyzer
  2. Beckman Coulter AU2700 Chemistry Analyzer
  3. Beckman Coulter AU400 Chemistry Analyzer
  4. Beckman Coulter AU640 Chemistry Analyzer
  5. Beckman Coulter AU680 Chemistry Analyzer
  6. Beckman Coulter AU480 Chemistry Analyzer
  7. 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