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Unicel DXC600i Synchron Access Integrated Clinical Systems, and Unicel DXI 800 and Unicel DXI 600 Access Immunoassay Systems (2014-05-10)
- Starting date:
- May 10, 2014
- Posting date:
- June 5, 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-39909
Recalled Products
a) Unicel DXC600i Synchron Access Integrated Clinical Systems
b) Unicel DXI 800 Access Immunoassay Systems - Class 3
c) Unicel DXI 800 Access Immunoassay Systems - Class 2
d) Unicel DXI 600 Access Immunoassay Systems - W/Spot B Gantry-Class 2
e) Unicel DXI 600 Access Immunoassay Systems - W/Spot B Gantry-Class 3
f) Unicel DXI 800 Access Immunoassay Systems
Affected products
a) Unicel DXC600i Synchron Access Integrated Clinical Systems
Lot or serial number
800023
Model or catalog number
4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
b) Unicel DXI 800 Access Immunoassay Systems - Class 3
Lot or serial number
600924
601128
601774
Model or catalog number
973100
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
c) Unicel DXI 800 Access Immunoassay Systems - Class 2
Lot or serial number
600924
601128
601774
Model or catalog number
973100
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
d) Unicel DXI 600 Access Immunoassay Systems - W/Spot B Gantry-Class 2
Lot or serial number
900778
Model or catalog number
A71460
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
e) Unicel DXI 600 Access Immunoassay Systems - W/Spot B Gantry-Class 3
Lot or serial number
900778
Model or catalog number
A71460
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
f) Unicel DXI 800 Access Immunoassay Systems
Lot or serial number
600924
601128
601774
Model or catalog number
973100
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES