Cocaine Metabolite Micro-Plate EIA (2018-01-16)

Starting date:

January 16, 2018

Posting date:

February 9, 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-65924

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  Reason
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  Affected products

Affected products

Cocaine Metabolite Micro-Plate EIA

Reason

Cocaine microplate kit failed the six month stability time point at initial testing, as well as the double operator repeat testing. A non-conformance report was initiated. The product may produce false positive patient results. The product provides only a preliminary analytical test result. A more specific alternative method should be used in order to obtain a confirmed analytical result.

Affected products