AQURE SYSTEM (2016-01-29)

Starting date:
January 29, 2016
Posting date:
January 29, 2016
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-56732

Affected Products

  1. AQURE SYSTEM

Reason

Radiometer has been made aware that the AQURE system, may display the sample type as "blank", if the sample type is not specified by the user. As multiple result values for the same patient and the same parameter can be displayed side by side on the screen, there is a potential risk of misinterpretation of results, the user may confuse the blank/unspecified sample type with the content of a specified sample type field.

Affected products

A. AQURE SYSTEM

Lot or serial number

Not applicable

Model or catalog number

933-599

Companies
Manufacturer
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK