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ABL90 Flex - Analyzer
- Starting date:
- January 11, 2017
- Posting date:
- February 1, 2017
- 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-62052
Reason
On the ABL90 analyzers the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous". The selected sample type is displayed correctly on the ABL90 analyzer itself. However, irrespectively of the sample type selected on the ABL90 analyzer during sample processing, the analyzer will transmit the less specific sample type "cord blood" to a hospital information system/laboratory information system (HIS/LIS) or middleware system.
Affected products
ABL90 Flex - Analyzer
Lot or serial number
Version 3.1 MR5
Model or catalog number
393-090
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK