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Iron Flex Reagent Cartridge
- Starting date:
- October 2, 2012
- Posting date:
- October 29, 2012
- 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-15167
Recalled Products:
Iron Flex Reagent Cartridge
Reason
Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with Iron Flex Reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of Iron Flex Reagent cartridges have the potential for this issue.
Affected products
Iron Flex Reagent Cartridge
Lot or serial number
More than 10 digits, contact manufacturer.
Model or catalog number
K3085
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.