This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
UniCel DxC 600i Synchron Access Clinical Analyzer (2014-08-04)
- Starting date:
- August 4, 2014
- Posting date:
- August 22, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41155
Recalled Products
UniCel DxC 600i Synchron Access Clinical Analyzer
Reason
DxC operating software version 5.4 was prematurely installed onto the UniCel DxC 600i Synchron Access Clinical Analyzer. This software version was intended for all other UniCel DXC system configurations, but not validated for the DxC 600i system configuration.
Affected products
UniCel DxC 600i Synchron Access Clinical Analyzer
Lot or serial number
2562
Model or catalog number
4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES