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Health product recall

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