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Unicel DXC 600 Pro and DXC 800 Pro Systems (2012-09-03)
- Starting date:
- September 3, 2012
- Posting date:
- November 25, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36831
Recalled products
- Unicel DXC 600 Pro
- Unicel DXC 800 Pro
- Unicel DXC 600I
Reason
Beckman Coulter has confirmed that the shuttle to barcode reader and CAP piercer alignment procedure cannot be performed on DXC Pro systems when the CAP piercer is disabled. There is no impact if the CAP piercer is not disabled and operating properly.
Affected products
A. Unicel DXC 600 Pro
Lot or serial number
- 139
- 1512
- 356
Model or catalog number
- 4764
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Unicel DXC 800 Pro
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4764
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Unicel DXC 600I
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES