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ABL90 FLEX - ANALYZER (2015-08-18)
- Starting date:
- August 18, 2015
- Posting date:
- September 24, 2015
- 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-54998
Affected Products
A. ABL90 FLEX - ANALYZER
Reason
In analyzers with older batteries (Run P0008 and below), the battery may overheat causing black smoke, burnt smell and loud noise. Temperature monitoring is in place to ensure shut down of the analyser upon overheating. However, heating of the cells may happen very fast, so that the temperature monitoring and shut down of the charging might not been able to stop the therminal runaway.
Affected products
A. ABL90 FLEX - ANALYZER
Lot or serial number
N/A
Model or catalog number
393-090
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK