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Dimension Vista System - Cyclosporine Extended Range (CSAE) and Cyclosporine (CSA) Assays (2014-03-14)
- Starting date:
- March 14, 2014
- Posting date:
- April 15, 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-39001
Recalled Products
A. Dimension Vista System - Cyclosporine Extended Range (CSAE) Assay
B. Dimension Vista System - Cyclosporine (CSA) Assay
Reason
There is the possibility of under-recovery of Dimension Vista Cyclosporine (CSA) and Cyclosporine Extended Range Assay (CSAE) when patient's samples are processed from the Small Sample Container (SSC). This field safety notice is for the non-expired lots of the Dimension Vista CSA/CSAE assays.
Affected products
A. Dimension Vista System - Cyclosporine Extended Range (CSAE) Assay
Lot or serial number
13157BC
13249BD
Model or catalog number
K4108
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Vista System - Cyclosporine (CSA) Assay
Lot or serial number
13114BA
13157BA
13246BB
13317BA
14008BB
14050BB
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