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Health product recall

Iscus Flex Analyzer

Starting date:
July 10, 2017
Posting date:
August 14, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-64128

Reason

M Dialysis is informing certain customers that they were sold an unlicensed class III medical device.

Affected products

Iscus Flex Analyzer

Lot or serial number

All serial numbers

Model or catalog number

8003295

Companies

Manufacturer
M Dialysis AB
HAMMARBY FABRIKSVAG 43
Stockholm
12030
SWEDEN