VisuLize Factor VIII Antigen Kit (2018-02-13)

Starting date:

February 13, 2018

Posting date:

February 22, 2018

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-66038

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  Reason
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  Affected products

Affected products

VisuLize Factor VIII Antigen Kit

Reason

The symbols for "lot" and "catalogue number" are incorrect in the legend of the French language version of the instructions for use.  The symbols on all vial labels and the English instructions for use are correct.

Affected products