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Access and Access 2 Immunoassay Systems (2017-11-06)
- Starting date:
- November 6, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-65252
Affected products
A. ACCESS IMMUNOASSAY ANALYZERS - CLASS 3
B. ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
C. ACCESS2 IMMUNOASSAY SYSTEM
Reason
Beckman Coulter (BEC) is initiating a field action for Access 2 systems due to a potential for a metal alignment tool to contact the low voltage PCB which can result in a minor skin burn. The tool is used only by BEC field service engineers and trained biomedical engineers.
Affected products
A. ACCESS IMMUNOASSAY ANALYZERS - CLASS 3
Lot or serial number
570212
Model or catalog number
81600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
Lot or serial number
570212
Model or catalog number
81600N
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. ACCESS2 IMMUNOASSAY SYSTEM
Lot or serial number
570212
Model or catalog number
81600N
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES