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ABL90 Flex - Analyzer (2014-12-19)
- Starting date:
- December 19, 2014
- Posting date:
- January 23, 2015
- 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-43421
Recalled Products
ABL90 Flex – Analyzer
Reason
Radiometer has recently become aware of a potential significant clinical issue with the results reported if or when the inlet is left open after aspiration of the patient sample, for more than 30 seconds.
Affected products
ABL90 Flex – Analyzer
Lot or serial number
All serial numbers.
Model or catalog number
393-090
Companies
- Manufacturer
-
Radiometer Medical APS
Akandevej 21
Bronshoj
2700
DENMARK