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AQURE SYSTEM (2016-01-29)
- Starting date:
- January 29, 2016
- Posting date:
- January 29, 2016
- 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-56732
Affected Products
- AQURE SYSTEM
Reason
Radiometer has been made aware that the AQURE system, may display the sample type as "blank", if the sample type is not specified by the user. As multiple result values for the same patient and the same parameter can be displayed side by side on the screen, there is a potential risk of misinterpretation of results, the user may confuse the blank/unspecified sample type with the content of a specified sample type field.
Affected products
A. AQURE SYSTEM
Lot or serial number
Not applicable
Model or catalog number
933-599
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK