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Health product recall

ABL90 Flex Analyzer (2013-10-24)

Starting date:
October 24, 2013
Posting date:
November 29, 2013
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-36913

Recalled Products

ABL90 Flex Analyzer

Reason

If the ABL90 flex analyzer is tilted it may cause a negative bias on sodium results up to 7% (minus 10mm).  This issue has been reported when the analyzer has been installed on a roll stand and tilted (i.e. the support plate is not horizontal).

Affected products

ABL90 Flex Analyzer

Lot or serial number

N/A

Model or catalog number

393-090

Companies
Manufacturer
Radiometer Medical APS
Akandevej 21
Bronshoj
2700
DENMARK