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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-15519
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 System will not read Codabar barcode labels at the primary reader under the following conditions:
- the leading and trailing characters do not match (e.g. a12345b)
- the Aim-16 checksum digit calculation is used with any leading and trailing characters that are not both "A."
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.