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Unicel DXH Slidemaker Stainer Coulter Cellular Analysis system, Software Version 1.5.1.0
- Starting date:
- November 1, 2012
- Posting date:
- December 10, 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-16323
Recalled Products
A. Unicel DXH Slidemaker Stainer Coulter Cellular Analysis system, Software Version 1.5.1.0
Reason
Beckman Coulter Inc. (BEC) has confirmed that the system manager on the Unicel DXH Slidemaker Stainer Coulter Cellular Analysis system, software version 1.5.1.0, will not allow the customers to change the time and date backward when following the Instruction for Use (IFU). This affects the ability of an operator to make the necessary time change adjustments for the changes from Daylight Savings Time (DST) to Standard Time.
Affected products
A. Unicel DXH Slidemaker Stainer Coulter Cellular Analysis system, Software Version 1.5.1.0
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
775222
Companies
- Manufacturer
- Beckman Coulter Inc.