Synchron Systems Cannabinoid (THC) Reagent (2019-08-31)

Starting date:

August 31, 2019

Posting date:

September 20, 2019

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-71015

Last updated: 2019-09-20

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  Reason
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  Affected products

Affected Products

Synchron Systems Cannabinoid (THC) Reagent

Reason

Studies indicate that cross-reactivity testing may not meet the claims indicated in the Cannabinoid 100 ng instructions for use (IFU) for 9 -THC or the claims indicated in the Cannabinoid 50 ng instructions for use (IFU) for Cannabinol and 9 -THC.

Affected products