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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