REMISOL ADVANCE (2021-03-22)

Starting date:

March 22, 2021

Posting date:

April 1, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-75299

Last updated:
2021-04-01

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  Reason
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  Affected products

Affected Products 

REMISOL ADVANCE

Reason

Instructions For Use for versions 1.5 to 1.9 do not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.

Affected products