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Access Immunoassay Systems (2017-03-13)
- Starting date:
- March 13, 2017
- Posting date:
- March 31, 2017
- 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-62840
Affected Products
- Access Immunoassay System - Analyzer Class 3
- Access System Access 2 Analyzer - Class 2
- Access2 Immunoassay System
Reason
Beckman Coulter has determined through internal investigation that a circuit board that controls motor functions in the affected instrument systems can affect device positioning on the pipettor and incubator belt while the instrument is running.
Affected products
A. Access Immunoassay System - Analyzer Class 3
Lot or serial number
512155
Model or catalog number
81600N
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Access System Access 2 Analyzer - Class 2
Lot or serial number
512155
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
512155
Model or catalog number
81600N
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES