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Dimension Products – Total Iron Binding Capacity (IBCT)
- Starting date:
- December 21, 2012
- Posting date:
- January 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 (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16671
Recalled Products
A. Dimension Clinical Chemistry – IBCT
B. Dimension Xpand System – IBCT
C. Dimension EXL System – IBCT
Reason
Through monitoring of method Performance Siemens has determined that the analytical sensitivity claim of 6 mcg/dl (1.1 mcmol/l) stated in the instructions for use is no longer valid for Dimension Total Iron Binding Capacity (ibct), and is modifying that claim to 36 mcg/dl (6.44 mcmol/l).
Affected products
A. Dimension Clinical Chemistry – IBCT
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
DF84
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
B. Dimension Xpand System - IBCT
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
DF84
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
C. Dimension EXL System – IBCT
Lot or serial number
More than 10 Numbers, Contact manufacturer
Model or catalog number
DF84
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.