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AQT90 Flex
- Starting date:
- February 23, 2017
- Posting date:
- March 16, 2017
- 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-62644
Reason
Radiometer has recently become aware that the internal temperature in the AQT90 Flex Analyzer under worst case conditions may slightly exceed acceptable storage conditions for AQT90 Flex on-board test cartridges. To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 Flex Analyzer has been adjusted to 30 degrees Celsius / 86 degrees Fahrenheit (down from 32 degrees Celsius/ 89.6 degrees Fahrenheit).
Affected products
AQT90 Flex
Lot or serial number
Not applicable
Model or catalog number
393-838
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK