ABL800 Analyzers (2018-06-19)
- Starting date:
- June 19, 2018
- Posting date:
- July 5, 2018
- 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-67176
Affected products
ABL800 Analyzers
Reason
The ABL800 analyzer could potentially induce patient mix-up when performing a query to AQURE, Radiance, or HIS/LIS system and “confirm pre-registered data” is enabled. The problem occurs if "confirmation of demographics" window is open because the user is in the process of updating a sample (e.g. sample #161) with patient demographics requested from HIS/LIS. If the user starts a new measurement (e.g. sample #165) before "confirmation of demographics" window is closed the new sample #165 will incorrectly be updated instead of #161 with the patient demographics shown in the "confirmation of demographics" window. Thus #165 is updated with patient demographics belonging to #161.
Affected products
ABL800 Analyzers
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
393-800
393-801
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK