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Unicel Dxh 800 and 600 Coulter Cellular Analysis System (2017-04-25)
- Starting date:
- April 25, 2017
- Posting date:
- May 16, 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-63312
Affected Products
A. Unicel Dxh 800 Coulter Cellular Analysis System
B. Unicel Dxh 600 Coulter Cellular Analysis System
Reason
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Affected products
A. Unicel Dxh 800 Coulter Cellular Analysis System
Lot or serial number
All lots
Model or catalog number
629029
B24802
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Unicel Dxh 600 Coulter Cellular Analysis System
Lot or serial number
All lots
Model or catalog number
B23858
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES