Product Wiki · Recalls · Health Canada — Medical Devices

HemosIL Factor XII Deficient Plasma (2017-07-17) — recall 60726

Health Canada — Medical Devices · Canada · 2018-03-13 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
60726
Date of alert
2018-03-13
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: HemosIL Factor XII Deficient Plasma are not meeting their labeled on-board instrument stability claim for the ACL Top Family and ACL Top Family 50 Series of 24 hours at 15 C, the affected lots numbers are only stable for 2 hours on-board the instrument. Consequently, there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hemosil-factor-xii-deficient-p

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