Multi-Drug Screen Test ECO II Cup (2018-08-16)

Starting date:

August 16, 2018

Posting date:

August 31, 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-67634

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  Reason
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  Affected products

Affected products

Multi-Drug Screen Test ECO II Cup

Reason

Name of the product on outer case and inner box label (urine drug of abuse test) is different from name on the medical device licence (Multi-Drug Screen Test ECO II Cup). Outer case, inner box are missing manufacturer name and address as required by mdr. Defectiveness was discovered during annual renewal of the device licence# 94297 on August 8, 2018.

Affected products