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ABL800 Flex System
- 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-62050
Reason
On the ABL800 series 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 analyzer itself. However, irrespectively of the sample type selected on the 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
ABL800 Flex System
Lot or serial number
Version 6.14
Model or catalog number
393-800
393-801
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK