Pain Management 100 (WB) (2016-08-17)

Starting date:

August 17, 2016

Posting date:

August 26, 2016

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-59998

• Reason
• Affected products

Affected Products

Pain Management 100 (WB)

Reason

Disregard the previous IFU for product pm 100 (wb) whole blood toxicology control.  The previous IFU claimed a higher reference value for the analyte methadone primary metabolite (eddp).  There is an indication at the bottom of the method table in the new IFU outlining that there is no claim made for expected values or stability.

Affected products