This page has been archived on the Web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.
Dimension Vista Systems (2013-10-15)
- Starting date:
- October 15, 2013
- Posting date:
- November 7, 2013
- 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-36631
Recalled Products
A. Dimension Vista System - Dimension Vista 1500 Analyzer
B. Dimension Vista System - Dimension Vista 500 Analyzer
Reason
Siemens Healthcare Diagnostics has confirmed that under a rare set of conditions when utilizing the routine inventory screen to enter a user defined method (Empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system, and then use the incorrect flex cartridge to process the user defined method. Investigation of the issue has determined that this error will only occur if the assign empty reagent cartridge window has been left open and the flex inventory on the system changes.
Affected products
A. Dimension Vista System - Dimension Vista 1500 Analyzer
Lot or serial number
All lots
Model or catalog number
- 1000033793
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Vista System - Dimension Vista 500 Analyzer
Lot or serial number
All lots
Model or catalog number
- 1000034648
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES