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Health product recall

ABL90 Flex - Analyzer (2014-12-19)

Starting date:
December 19, 2014
Posting date:
January 23, 2015
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-43421

Recalled Products

ABL90 Flex – Analyzer

Reason

Radiometer has recently become aware of a potential significant clinical issue with the results reported if or when the inlet is left open after aspiration of the patient sample, for more than 30 seconds.

Affected products

ABL90 Flex – Analyzer 

Lot or serial number

 All serial numbers.       

Model or catalog number

393-090

Companies
Manufacturer
Radiometer Medical APS
Akandevej 21
Bronshoj
2700
DENMARK