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UniCel DxC 600I Synchron Access Clinical Analyzer and Access 2 Immunoassay Systems (2014-09-28)

Starting date:
September 28, 2014
Posting date:
October 9, 2014
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-41711

Recalled Products

A) UniCel DxC 600I Synchron Access Clinical Analyzer
B) Access 2 Immunoassay Systems- Analyzer Class III
C) Access 2 Immunoassay Systems- Analyzer Class II
D) Access 2 Immunoassay Systems

Reason

Beckman coulter has determined that the Access 2 console PC (B23083) may experience an "MFC exception" error during normal operation. If this error occurs, the system will exit the Access 2 user interface (UI) screen and display a window that notifies the user of a "0==I tubes can count" event. If the UI is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same "MFC exception" error will occur.

Affected products

A) UniCel DxC 600I Synchron Access Clinical Analyzer
 

Lot or serial number

800074
800135

Model or catalog number

4767

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

B) Access 2 Immunoassay Systems- Analyzer Class III
 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

81600N

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

C) Access 2 Immunoassay Systems- Analyzer Class II
 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

81600N

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

D) Access 2 Immunoassay Systems

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

81600N

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES