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Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Part Number 775222, Software Revision 1.5.1.0
- Starting date:
- October 4, 2012
- Posting date:
- October 29, 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-15136
Recalled Products:
Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Part Number 775222, Software Revision 1.5.1.0
Reason
The DXH SMS (Slidemaker Stainer) System is generating an "invalid code" message (error code 75) when the LIS transmits any field in the record that is not populated (nil). The LIS will retransmit the test order to the analyzer and the DXH SMS will reject the retransmission and send a message to the LIS that the test order was already received/processed.
Affected products
Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Part Number 775222, Software Revision 1.5.1.0
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
775222
Companies
- Manufacturer
-
Beckman Coulter Inc.