Product Wiki · Recalls · Health Canada — Medical Devices

COBAS MIRA SYSTEM - LIPASE ASSAY (2015-07-02) — recall 53937

Health Canada — Medical Devices · Canada · 2015-08-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53937
Date of alert
2015-08-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The manufacturer has identified that the Lipase Assay was showing occasionally calibration and QC failures associated to on-board reagent stability that have trigger the need to have the reagent shelf-life to be reduced from 15 to 9 months.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-mira-system-lipase-assay

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