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Unicel DXH 800 Coulter Cellular Analysis System
- Starting date:
- August 16, 2012
- Posting date:
- September 17, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15520
Recalled Products
A. Unicel DXH 800 Coulter Cellular Analysis System
Reason
The Unicel DXH 800 Coulter Cellular Analysis System with Revision 2.0.0.1 Software transmits the White Blood Count (WBC), Red Blood Count (RBC), and Platelet (PLT) Histograms with an incorrect identifier to the host, causing the host to not be able to retrieve the data. All languages are impacted by this issue.
Affected products
A. Unicel DXH 800 Coulter Cellular Analysis System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
629029
Companies
- Manufacturer
- Beckman Coulter Inc.