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Dimension Vista System - Cyclosporine (CSA Assay) (2013-12-04)
- Starting date:
- December 4, 2013
- Posting date:
- February 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37541
Recalled Products
Dimension Vista System - Cyclosporine (CSA Assay)
Reason
Siemens Helathcare Diagnostics has confirmed the possibility of variability in recovery of QC and patient results with the Dimension Vista CSA flex reagent cartridge lots 12300BB, 12318BB, and 13011BB. Internal studies have shown an upward trend in recovery over the three day open well est claim.
Affected products
Dimension Vista System - Cyclosporine (CSA Assay)
Lot or serial number
12300BB
12318BB
13011BB
Model or catalog number
K4089
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES