Product Wiki · Recalls · Health Canada — Medical Devices

Pain Management 100 (WB) (2016-08-17) — recall 44351

Health Canada — Medical Devices · Canada · 2016-08-26 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44351
Date of alert
2016-08-26
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/pain-management-100-wb-2016-08

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