Abl90 Flex - Analyzer

Starting date:

September 8, 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-60262

• Reason
• Affected products

Affected Products

Abl90 Flex - Analyzer

Reason

It has been discovered that the feature "exit conditioning" may cause a risk to patients. When a new sensor cassette is installed, the analyzer will automatically run extra calibrations and internal QC's for the first 24 hours. It is possible, during sensor cassette start-up to press "exit conditioning". This will cancel the second start-up calibration and the 3 start-up QC's. It will not affect the remaining frequent calibrations. The analyzer does not indicate the exit from the conditioning and the patient results are not flagged for QC not being run.

Affected products