Health product recall

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