Product Wiki · Recalls · Health Canada — Medical Devices

MAS Omni IMMUNE Systems (2014-04-02) — recall 56526

Health Canada — Medical Devices · Canada · 2016-11-25 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56526
Date of alert
2016-11-25
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 constituent, inhibin A, was removed from MAS Omni-IMMUNE and MAS Omni-IMMUNE Pro Controls. However, the package insert was not updated to reflect removal. The affected lots should not be used as control material for monitoring inhibin A assays. No other analytes of the MAS Omni-IMMUNE and MAS Omni-IMMUNE Pro Controls are affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mas-omni-immune-systems-2014-0

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