ZYMUTEST HIA IgGAM MonoStrip (2018-02-06)

Starting date:

February 6, 2018

Posting date:

March 23, 2018

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-66266

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  Reason
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  Affected products

Affected products

ZYMUTEST HIA IgGAM MonoStrip

Reason

A typographical error was identified in the Information for Use (IFU) for the ZYMUTEST HIA MonoStrip. On the section "test procedure" for the reconstitution volume of the immunoconjugate reagent, 7.5ml is written instead of 2ml of conjugate diluent.

Affected products