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Dimension Products – Iron Calibrations
- Starting date:
- December 24, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-16673
Recalled Products
- Dimension Clinical Chemistry System – (Iron Flex Reagent Cartridge)
- Dimension Xpand System – Iron Assay
- Dimension EXL System – Iron Assay
Reason
Complaints received regarding iron calibrations outside of acceptable Calibration Slope (M) values (0.97-1.03) when using Iron Calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints received.
Affected products
A. Dimension Clinical Chemistry System – (Iron Flex Reagent Cartridge)
Lot or serial number
2DN060, 2FN063, 2GN068, 2JN074
Model or catalog number
DC85
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
B. Dimension Xpand System – Iron Assay
Lot or serial number
2DN060, 2FN063, 2GN068, 2JN074
Model or catalog number
DC85
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
C. Dimension EXL System - Iron Assay
Lot or serial number
2DN060, 2FN063, 2GN068, 2JN074
Model or catalog number
DC85
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.